Careers at NanoString

Join Our Team

NanoString Technologies seeks the best and the brightest to join us in our mission to provide innovative tools and technologies to researchers and scientists around the globe. Working at NanoString provides the opportunity to contribute to the discovery and development of new therapies for better patient outcomes. If you want to impact the human health and are creative, passionate, and enjoy being part of a high-energy team that thrives on scientific and product excellence, we would like to hear from you!

We offer competitive salaries and a comprehensive benefits program, and the opportunity to advance your professional growth and career aspirations.

NanoString Technologies is an Equal Opportunity Employer (EOE).

NanoString Technologies participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). Please read the below notices, available in English and Spanish, for important information. Please go to the USCIS E-Verify website for additional information.

For more information about NanoString Technologies, please visit our company overview.

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Experienced

Nanostring is always interested in knowing the best and the brightest talent. If you do not see a job that matches your background at this time we encourage you to apply for this future emploment posting. This will help us find you if a new need arises that fits your experience. Please continue to view our career page as well but this will help the relationship begin.

THIS NOT AN ACTUAL JOB. THIS IS PURELY FOR THE FUTURE (POTENTIAL) JOBS.

***If you have applied for any position previously your resume is already in our database-NO need to re-apply***

 

 


Research & Development

Department: Research & Development

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Experienced

Job Summary:

We are seeking an Engineer to join our Research and Development group.  In this role you will work on the development of new genomic tools that consist of instrumentation, consumables, and chemistry. In particular, this position is focused on the development of the recently announced Hyb & Seq TM technology (NGS), a novel single-molecule hybridization-based sequencing chemistry. The work is highly interdisciplinary will involve working closely with biologists, scientists, software engineers, and external OEM manufacturers.  The applicant will be expected to have strong verbal and written communication skills and will be expected to manage communication with OEM partners.  The position will involve development of instrumentation as well as testing of designs: both fluidic and optical systems. The applicant will be expected to help automate Hyb and Seq sample prep by prototyping hardware to run microfluidic cards, as well as, support optical development efforts

Essential Duties:

  • Develop commercial instrument systems
  • Design hardware related to imaging and fluidics
  • Rapid prototyping
  • Strong Knowledge of Solidworks

Requirements:

  • Degree in mechanical, mechatronic, optical, or related engineering field
  • B.S. 4+, M.S + 4-6 years experience
  • Experience with design mechanisms and instrument systems
  • Experience with design of optical systems
  • Experience with design and automation of fluidic systems
  • Instrument prototyping through development and assembly of breadboard systems
  • A hands-on orientation toward experimentation and rapid prototype development
  • Ability to carry out experiments to verify performance of designs
  • Ability to work both independently and closely in collaboration with a core team
  • Excellent verbal and written communication skills
  • Strong proficiency in CAD (Solidworks preferred)

Additional qualifications include:

  • Experience designing mechanical components for optic assemblies
  • Experience with fluidics/microfluidics and or pipetting robots
  • Experience with microscopy
  • Experience with design/selection of hardware to control microfluidics: pumps, valves, and manifolds.
  • Experience with hardware/consumable development for genomics
  • Flow cell design and fabrication
  • Experience operating machine shop equipment: Mill, lathe, laser cutter, 3D printer, etc.
  • Automation of repetitive activities through script-level programing and/or C.

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

Department: Research & Development

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Mid Level

Job Summary:

We are seeking a Research Associate II or III to join our Research and Development group. In this role, you will work on the development of Hyb & Seq™, a novel single-molecule hybridization-based next generation sequencing (NGS) technology.  Specifically, this role will involve developing novel Hyb & Seq reagents and protocols, creating and validating targeted sequencing panels.  A strong background in molecular biology is required.  Experience with NGS wet-lab techniques (any platform) is preferred.  The work is highly interdisciplinary and will involve working with biologists, engineers, and bioinformaticians.  The applicant will be expected to have strong verbal and written communication skills.  The applicant will be expected to work as part of a team while executing experiments independently.

WORK SCHEDULE: You can chose either Thursday thru Monday - OR - Friday thru Tuesday. Prefer an early schedule of 6:00 AM to 2:00 PM (open to some variance).

Essential Duties:

  • Design, carry out and interpret experiments with limited supervision
  • Organize and communicate results to supervisor and senior management verbally and/or in writing
  • Perform 80-90% bench work on specified projects
  • Work cooperatively in a product-oriented team environment
  • Deliver results under tight timelines
  • Present data to product development teams and management representatives
  • Write protocols, experimental summary reports, quality documents and other scientific literature associated with projects
  • Analyze large, complex data sets using spreadsheets and/or other data analysis packages

Requirements:

  • B.S. in biochemistry, molecular or cellular biology or a related discipline
  • 2-6 years of hands-on experimental experience
  • Strong wet bench, molecular biology experience
  • Experience with cloning, ligations, nucleic acid purification, and other nucleic acid chemistry is preferred
  • NGS experience, either sample preparation or analysis, is preferred.

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

Department: Research & Development

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Experienced

Job Summary:

The Principal Biostatistician is responsible for developing the Biostatistics vision in collaboration with Bioinformatics, leading the Biostatistics efforts across all products and platforms at NanoString, and managing the Biostatistics team. This individual acts as principal lead in designing and reporting of statistical analyses in support of the development of products for life science research and diagnostic development.  This individual will also be responsible for working closely with the Bioinformatics team, R&D team, and commercial team to develop new content and analysis methods for products on the nCounter, DSP, and Hyb&Seq platforms.

Essential Duties:

  • Analyzing the statistical integrity and accuracy of data generated during development of in vitro diagnostic assays and new RUO assays
  • Acts as principal lead in designing and reporting of statistical analyses of studies and experiments in support of the development of products for life science research and clinical diagnostics
  • Works closely with scientists and engineers to ensure proper use of statistical methodology and interpretation of results generated by the R&D team as well as assisting customers with complex data analysis problems
  • Lead the statistical evaluation of new signatures and candidate biomarkers for translation to clinical use on the nCounter, DSP, and Hyb&Seq systems
  • Works closely with research scientists, commercial team to drive and lead the Biostatistics component of the development of analyses for new products for the nCounter, DSP, and Hyb&Seq platforms
  • Lead the Biostatistics team and provide vision and guidance to support both internal R&D product and assay development activities as well as support external customers
  • Works with closely with the R&D team developing the vision and content for new statistical analysis methods for identifying content and creating relevant signatures and analysis for future content on the nCounter, DSP, and Hyb&Seq platforms

Requirements:

  • Ph.D. degree in the biological sciences, bioinformatics, statistics, or a related field
  • 7+ years related experience in the statistical analysis of biological data
  • Expertise in statistical programming in R, SAS, JMP, or related data analysis tools
  • Experience in writing statistical plans, protocols, and reports
  • Strong knowledge of signature and biomarker discovery and development
  • Expertise in the analysis of large genomics datasets from DNA and RNA microarrays, quantitative PCR and NGS from both public (TCGA) and private sources
  • Familiarity with current literature on genomic and expression biomarkers and signatures
  • Experience in analyzing clinical datasets including survival data
  • Proficiency in the design of experimental protocols including power calculations
  • Background in cancer biology or bioinformatics/computational biology preferred
  • Excellent verbal and written communication skills

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

Department: Research & Development

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Senior Manager/Supervisor

Job Summary:

NanoString is seeking an experienced development scientist to join the Product Development group. This position will have a leading role in developing, integrating and transferring assays/reagents for the Hyb & SeqTM platform to a ISO-13485 / 820-CFR compliant manufacturing environment. S/he will lead a reagent and assay product development team as well as interact and coordinate with a highly interdisciplinary group of developers. Candidates must have strong analytical skills, strong oral and written communication skills, and a proven track record of integrated system development experience in a regulated environment. Ideal candidates will have expertise in NGS development.

Essential Duties:

  • Apply advanced scientific and product development expertise to NGS platform development
  • Conceive, design and ensure execution of experiments to advance development of reagents and assays in conjunction with research teams utilizing design for manufacturing (DFM) principles
  • Conceive, design and ensure execution of product verification/validation
  • Establish, document and transfer to manufacturing material specifications and test methods for reagents and consumables
  • Define product structure and collaborate with research and process development to transfer design to the manufacturing environment
  • Work interactively with biophysicists, nucleic-acid chemists, fluorescence imaging specialists, and hardware and software engineers for full platform development
  • Translate early stage research into commercial products and reagents

Requirements:

  • Ph.D. in Life / Physical Sciences
  • 10+ years of industry experience in product development, with significant portion dedicated to NGS reagent/platform development
  • A minimum of 3 years of experience in managing product development personnel
  • Extensive hands-on, state-of-the-art molecular biology experience and knowledge of nucleic acid thermodynamics
  • Experience developing products within an ISO-9001/13485 and/or 820-CFR compliant product development setting

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

Department: Research & Development

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Mid Level

Job Summary:

NanoString is seeking an NGS Scientist to join a dynamic, fast-paced team-oriented environment to develop novel Illumina library preparation methods for profiling RNA from formalin-fixed paraffin embedded (FFPE) samples.  This work will be developed in conjunction with NanoString’s recently announced Digital Spatial Profiling (DSP) technology, which allows precise spatial digital quantification of proteins and gene expression. The ideal candidate will be a highly skilled molecular biologist or nucleic acid chemist with experience or working knowledge in in situ hybridization, gene expression profiling, Illumina sequencing systems, and NGS data analysis.  You will design and execute advanced research and NGS experiments to demonstrate feasibility of innovative spatial gene expression technologies as well as contribute to the analysis of large complex NGS data sets.  You will participate in a larger cross-functional DSP team to meet internal and external deadlines to deliver high quality, robust new products.  A successful candidate for this role is a hands-on problem-solver in the lab with excellent analytical skills and strong oral and written communication skills. You will be both a strong individual contributor as well as a collaborative team member.  A track record of independent research and development in RNA-Seq is preferred.

Essential Duties:

  • Apply expert NGS knowledge and wet-bench skill to develop high-throughput NGS library preparation method for sequencing on Illumina systems
  • Design and carry-out experiments for fast development of prototype library procedures for feasibility testing in conjunction with DSP technology developers
  • Develop and evaluate innovative NGS assays for gene expression profiling in FFPE tissue
  • Optimize current NGS library preparation protocols for high quality and robust performance
  • Analyze large complex NGS data sets
  • Work interactively with biophysicists, nucleic-acid chemists, fluorescence imaging specialists, bioinformaticists, engineers, and hardware and software developers

Requirements:

  • Ph.D. in genomics, molecular biology or biochemistry with experience in assay development in an academic or industrial laboratory
  • 2+ years of combined industry and/or post-doctoral work experience in NGS using Illumina platforms, with large portion preferably dedicated to RNA-Seq or single-cell RNA-Seq (Ph.D work in this area will also be considered as relevant work experience)
  • Extensive hands-on, state-of-the-art molecular biology experience in nucleic acid analysis and manipulation, including DNA and RNA purification, amplification, hybridization, etc.
  • Working knowledge of DNA and RNA enzymology including polymerases, ligases, nucleases, modification enzymes, etc.
  • Solid understanding of standard NGS bioinformatic tools and/or experience in building NGS data analysis pipelines. 
  • Excellent skills in experimental design, implementation, troubleshooting, and data analysis
  • Must be detail oriented and highly motivated; independent yet enjoys working in a multidisciplinary, collaborative team environment
  • Able to work effectively under pressure to meet scheduled deadlines and to handle multiple activities simultaneously
  • Excellent oral and written communication skills

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

Department: Research & Development

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Experienced

Job Summary:

NanoString is seeking a highly motivated and technology-savvy scientist, who will join R&D.  This position will have a key role on the development of a novel new spatial profiling technology, an approach for measuring expression levels of proteins and nucleic acids in a highly multiplexed manner in specific areas of tissues (a new paradigm in Digital Immunohistochemisty). The work is highly interdisciplinary and will involve working closely with biologists, hardware and software engineers, and external customers.  Successful candidate must be passionate about wet-lab driven experimentations to find innovative solutions to development hurdles.  Candidate must have strong analytical skills, strong oral and written communication skills, and strong track record of independent as well as collaborative research and development.

Essential Duties:

  • Take initiatives to conceive, design and carry-out hypothesis driven feasibility experiments to drive the development of the chemistry as well as inform the design of the hardware/software.
  • Strong understanding both theoretical and practical aspects of the experimental design
  • Drive wet-bench experimentation and subsequent data analysis/interpretation activities
  • Work interactively with biophysicists, nucleic-acid chemists, fluorescence imaging specialists, and hardware/software engineers

Requirements:

  • Ph.D. in immunology, cancer-biology, biochemistry, molecular biology, or related field.
  • 2+ years of industrial and/or post-doctoral work experience
  • Extensive experience with human immune-oncology
  • Extensive experience with Immunohistochemistry (IHC)
  • Strong wet bench and assay development skills related to consumable reagents development.
  • Experience with imaging and assays involving tissue preparations, especially FFPE (formalin fixed paraffin embedded) tissue.
  • Excellent verbal and written communication skills
  • Experience with protein detection methodologies, proteomics, multiplexed protein assays and handling antibodies
  • Experience with RNA and DNA sample preparation, genomics and a wide variety of nucleic acid protocols
  • High degree of computer literacy with frequently used software such as Microsoft Word, PowerPoint, Project Management, Excel, ImageScope.
  • Experience with client management skills

Additional Qualifications include:

  • R and python experience preferred
  • Experience in next generation sequencing is plus.
  • Experience with scripting and automation of laboratory equipment / microscopes for new assay workflow development
  • Experience with fluorescence-based detection technologies including single molecule detection
  • Experience with bright field and fluorescent microscopy applied to tissue and cellular imaging.

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

Department: Research & Development

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Entry Level

Job Summary:

The Biostatistician I ensures statistical integrity and accuracy of research data and performs statistical design, modeling, and analyses.  This individual provides statistical summaries and reports of studies in support of product development, content development, and works with scientists and engineers to ensure proper use of statistical methodology and interpretation of results.  This individual will contribute to the development and expansion of data analysis methods and tools for the nCounter and other platforms.

Essential Duties:

  • Development and discovery of gene-expression based signatures diagnostics
  • Development of novel statistical methodology for the analysis of gene expression, proteomics and sequence data 
  • High-level applied analyses of gene expression and multiomics data
  • Statistical consultations with scientists throughout the company
  • Development of software to help biologists analyze omics data
  • Contribute to analysis of data for internal projects, external collaborators, as well as fee-for-service analysis projects
  • Work in collaboration with statisticians, bioinformaticists, and biologists
  • R&D efforts of your own devising

 

Requirements:

  • Master's or Ph.D. in statistics/biostatistics
  • 1-3 years of relevant work experience
  • Advanced R programming skills
  • Graduate-level coursework in applied statistics
  • Knowledge of molecular/systems biology strongly desirable
  • Knowledge of cancer biology strongly desirable
  • Experience in genomics and machine learning desirable
  • Experience in Python or other programming language preferred
  • Proven history of problem solving using statistical methods and tools in genomics

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

Department: Research & Development

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Student (College)

Job Summary:

The Bioinformatics/Biostatistics Intern works closely with research scientists and the rest of the computational team and is responsible for working on specific projects as assigned by the other team members. These projects could involve data analysis, consulting, data acquisition from public databases, etc.  This individual is expected to have broad technical knowledge of molecular biology, experience working with complex data-sets, and experience applying computational methods to biological research. Additionally, under the guidance of mentor(s) the intern may be directed to develop novel methods identified as key to computational initiatives.

Essential Duties:

  • Work with internal and external genomics / sequence databases for novel projects
  • Interact with the computational team to support internal tool development and advancement of analyses, and processes
  • Interact with R&D scientists and RAs to provide Bioinformatics/Biostatistics support for internal R&D efforts
  • Participating in project teams
  • Provide data analysis support for select internal or external projects

Requirements:

  • Currently enrolled in a bachelors or graduate level program with strong emphasis on computational research. Training in statistics and fluency with R as well as basic understanding/interest in genomics would be highly preferred
  • Strong problem solving and analytic skills
  • Excellent interpersonal skills, team oriented outlook, enthusiasm working closely with scientists
  • Familiarity with microarray data analysis, RNA-Seq data analysis tools, comparative genomics, and common bioinformatics software tools
  • Knowledge of SQL, PERL, Python, .NET or other languages preferred
  • Can communicate relevant data effectively in oral and written formats
  • Ability to work independently and in a team environment and balance multiple tasks in parallel​

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

Department: Research & Development

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Mid Level

Job Summary:

NanoString Technologies is seeking an experienced Scientist to join our Product Development team.  In this position, S/he will work with a cross functional team to develop new molecular diagnostic and companion diagnostic products with a particular focus in Oncology.  S/he will be responsible for developing and validating novel diagnostic gene signature assays on the nCounter Dx Analysis System.  S/he will be required to design experiments to test gene signature assays and analyze genomics/gene expression data, write test plans and reports, and work cross functionally to transfer reagents and assay testing procedures to a production or clinical environment.  S/he will be expected to provide technical leadership and communicate results to the cross functional team, as well as contribute as an individual researcher.

Essential Duties:

  • Design experiments to test the sensitivity, specificity, and reproducibility of new diagnostic gene signature assays
  • Analyze genomics data 
  • Develop assay procedures required for new gene signature assays
  • Use molecular biology techniques to develop and validate new molecular diagnostic reagents for use in diagnostic gene signature assays
  • Work as part of cross functional team to deliver new diagnostic products on tight timelines

Requirements:

  • Ph.D. in molecular biology, biochemistry, chemistry, biophysics or related field with a minimum of two years of relevant post-doctoral or work experience, or an M.S. with a minimum of 6 years of relevant work experience.
  • Extensive knowledge of nucleic acid manipulation and characterization techniques (i.e., NGS, Q-PCR or hybridization assays)
  • Familiarity with statistical approaches and software tools used for the analysis of gene expression data
  • Detailed understanding of state-of-the-art molecular biology techniques
  • Strong analytical and organizational skills exemplified by clear oral presentations and written documentation
  • Preferences for experience working in an ISO certified or QSR certified facility and experience developing products for the life sciences and/or molecular diagnostics industries
  • Preferences for experience working in the field of immuno-oncology

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

Department: Research & Development

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Experienced

Job Summary:

NanoString Technologies is seeking an energetic, outgoing, and detailed-oriented Project Manager to join our team.  Responsibilities include managing the development of new diagnostic and companion diagnostic products on the nCounter Analysis System, from Concept Phase through Commercialization Phase, according to our ISO 13485 compliant design & development lifecycle.  Scope includes mid- to large-size projects encompassing instrumentation, assay, software, reagents, and consumables.  This mid to senior-level Project Manager will work across R&D, Marketing, Regulatory, Clinical, Quality, Manufacturing, and external subject matter experts.

Essential Functions:

  • Bring together project resources and lead kick-off and cross-functional team meetings
  • Establish and maintain the product's Design History File (DHF)
  • Write product development plans in consultation with subject matter experts
  • Establish and manage product development timelines and track their execution
  • Gather product requirements from marketing and key stakeholders
  • Establish project scope definition and manage change control
  • Budget generation, tracking, reconciliation, and reporting
  • Center of communication between NanoString, Collaborators, and Pharma partners
  • Assist Regulatory in the development of Pre-Submissions, 510(k)'s, PMA's and ROW registration activities as applicable
  • Communicate and formally present project status to senior management

Requirements (Education, Experience, Specific Skills):

  • Experience managing medical device (Class II/III), diagnostic and/or companion diagnostic projects highly desired
  • Clinical trial (Ph II/III) and CRO experience desired
  • Experienced in Risk Management and knowledge in BS EN ISO 14971:2012 preferred
  • Comfortable working within electronic quality management systems (e.g. MasterControl, Agile)
  • Minimum of 5 year working directly as a Project or Program Manager
  • BS degree or higher in a scientific or engineering discipline required, MBA a plus
  • PMP certification or University Project Management certificate highly desired

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

Department: Research & Development

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Experienced

Job Summary:

NanoString Technologies is seeking an energetic and highly motivated senior/lead Software Test Engineer to join our Software Engineering team.  The Software Test Engineer is responsible for planning and executing software integration testing and system verification testing of embedded software products on Microsoft Windows in accordance with NanoString’s ISO 13485 quality system procedures.  You will coordinate and review the work of other SW Test Engineers, review requirements, and participate in test design and test execution for a fully-automated digital gene sequencing platform with embedded touchscreen, local web, and cloud interface.  A successful candidate will have a proven ability to independently prioritize and manage multiple tasks and projects with competing priorities and deadlines. The Software Test Engineer 4 role requires increased autonomy, project management, and personnel supervision.  

Essential Duties:

  • Responsible for test planning and design.
  • Review and update requirements for testability, traceability, and completeness.
  • Participate in risk analysis.
  • Estimate team effort on testing tasks.
  • Develop and execute test plans and protocols.
  • Review test protocols developed by other team members.
  • Coordinate testing activities among team members, including both manual and automated testing.
  • Write test reports.
  • Document traceability to ensure that the system software meets all requirements.

Requirements:

  • Bachelor’s degree in Computer Science, Engineering, or a related field.
  • 7+ years of experience in a software test role which includes testing software on a Microsoft Windows platform.
  • Demonstrated ability to plan, design, and execute software tests.
  • Demonstrated ability to coordinate the work of others.
  • Very good verbal and written communication skills.
  • Working knowledge of QSR Design Control (FDA 21 CFR Part 820) and/or IEC 62304 highly desired.
  • System test experience for class II or III medical device highly desired.
  • Experience with next generation sequencing software highly desired.
  • Experience developing test automation a plus.

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

IND123

Department: Research & Development

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Experienced

Job Summary:

NanoString Technologies is seeking a Research Associate IV to join our Diagnostic Development team.  This individual will work with a cross functional team to develop new molecular diagnostic and companion diagnostic products with a focus in Oncology.  This individual will conduct stability testing on reagents used in gene signature assays.  This individual will also work with product development Scientists to extract RNA from tissue and develop standard operating procedures and protocols for gene signature assays performed on the nCounter Dx Analysis System.  This individual will also assist in managing reagent and sample inventory, as well as transferring new processes from an R & D environment to a production or clinical environment.

Essential Duties:

  • Perform molecular biology protocols to develop new assay reagents
  • Conduct stability testing on reagents used in gene signature assays
  • Perform gene signature assay testing on the nCounter Dx Analysis System
  • Extract nucleic acids from tissue samples
  • Manage sample and reagent inventory for studies
  • Organize and manipulate data in Excel
  • Develop standard operating procedures and testing protocols

Requirements:

  • B.S. in molecular biology, biochemistry, bioengineering or related field with a minimum of 8 years of relevant laboratory experience, or M.S. with commensurate experience
  • Experience performing molecular biology protocols including nucleic acid manipulation and characterization techniques
  • Familiarity with tools used for the analysis of gene expression such as NGS or Q-PCR.
  • Previous product development experience within the molecular diagnostics or life sciences industry is strongly preferred
  • Strong written and verbal communication skills
  • Ability to work both independently and as a member of a project team
  • Proven ability to meet defined schedules and deadlines

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

Department: Research & Development

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Experienced

Job Summary:

NanoString is seeking a scientifically oriented Software Developer to join our Research & Development group. The position involves a variety of image processing, data acquisition and instrument control projects for a pair of novel instruments that are currently in development. The technology behind both instruments (Hyb & SeqTM and Digital Spatial Profiling) is built upon NanoString's extensive experience with DNA chemistry and fluorescence microscopy. NanoString's work environment is highly interdisciplinary. The successful applicant will interact with biologists, chemists, mathematicians and hardware/software engineers. 

Essential Duties:

  • Multi-channel (4+) image processing
  • Data acquisition with scientific cameras and various measurement devices
  • Instrument control for fluorescence microscopes that contain XYZ translation stages, tilt stages, and microfluidics
  • Automation of instrument control, image acquisition, and data analysis pipelines

Requirements:

  • M.S. or Ph.D. in a relevant field such as electrical engineering, computer science, bioengineering, physics, biophysics, or mathematics.  B.S. with sufficient experience is also acceptable.
  • 3-8 years of programming and 2+ years working in industry
  • Image analysis to segment cellular boundaries, count objects, measure areas, and extract features
  • Applied mathematics and algorithm development for numerical image processing
  • Rapid prototyping of algorithms and automation sequences during development of new technologies (instruments, chemistries, etc.)
  • Instrument control of micro-positioning and micro-fluidic devices
  • Data acquisition from cameras, sensors, and other measurement devices
  • MS Visual Studio development environment
  • C#, C/C++, or Java (NanoString uses C#)
  • Version control and software maintenance procedure

Beneficial Experience:

  • Fluorescence microscopy of biological tissue samples
  • MATLAB, Python, and other scripting environments
  • Translation of MATLAB and Python scripts into compiled languages (e.g. C#)
  • Microsoft TFS and Windows Workflow Foundation
  • Software development in a commercial environment
  • Automation and testing through script-level programing and/or .NET.
  • Vector processing technologies (e.g. Intel AVX-512 or GPUs)
  • Parallel processing technologies and algorithms (e.g. multi-threaded applications, OMP, etc.)

 

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

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Diagnostics Marketing

Department: Diagnostics Marketing

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Experienced

Job Summary:

The Senior Director, Diagnostics Marketing will provide leadership and direction of NanoString’s diagnostics marketing and commercialization strategies, on a worldwide basis. S/he will be a critical thought partner to NanoString’s Sr.VP Corporate and Business Development, CMO, VP Global Diagnostic Commercialization and other executives, including the CEO. The position holder will have the strategic capability to create sustainable markets for state of the art, precision diagnostics for some of the most exciting new drugs in oncology, such as those emerging in the field of Immuno-Oncology.

NanoString is a company at the forefront of developing and commercializing new diagnostics in a turbulent environment with shifting agency guidance, rapidly changing technologies, societal and payor pressures on the costs of combination therapies of new drugs and a need to capture increased value from diagnostic tests, compared to traditional diagnostics. In this environment, the Senior Director, Diagnostics Marketing must have the commercial gravitas to immediately gain the respect and credibility of existing and future Pharma partners, understand their concerns and speak their language. Equally, the position holder will also need to have credibility with the payors, regulators and other key stakeholders.

The Senior Director, Diagnostics Marketing will be responsible for brand management of each of NanoString’s diagnostics, directing the development of commercial plans for these brands and associated implementation to penetrate markets. The position holder will assign budgets, control costs and execute against the annual plan. S/he will be responsible for strengthening NanoString’s diagnostics marketing group, on a continuing basis, to form a best-in-class team for commercializing emerging diagnostics, as recognized by the company’s Pharmaceutical partners and other stakeholders.

This position holder reports to VP Global Diagnostic Commercialization, with a team in the US and Europe.
 

Essential Functions:

  • Development of annual plans, budgets and sales forecasts with the Diagnostics Marketing Team, Worldwide VP of Sales and Finance department and commercial input into NanoString’s annual long range planning (LRP) process.
  • Conceptualize and articulate a clear vision for the business that engages all functional areas and stakeholders.
  • With the Sr. VP Corporate and Business Development, lead diagnostics capability presentations to future pharma partners and develop sustainable business models for the resulting diagnostics products.
  • Represent and champion NanoString’s diagnostics business externally to executive level pharma, the payor community, leading clinical thought leaders, stakeholders and BoD members.
  • Work with the CMO to provide commercial inputs and underlying rationale to support clinical study designs, whilst having the flexibility to be receptive to different ways to deliver commercial needs through the clinical program.
  • Partner with the market access team, global sales, medical affairs and regulatory affairs to ensure goals are aligned across the diagnostics business and NanoString’s diagnostic brands.
  • Leadership of the diagnostics team and development including: hiring exceptional talent, performance management, annual goal setting and employee development and motivation.

Requirements:

  • Minimum of 10 years relevant clinical marketing experience; ideally gained in both the diagnostics and pharmaceutical sectors, preferably oncology. A minimum of 5 years of experience, at the Director/Senior Director Marketing level and substantial line management experience.
  • Global marketing experience and associated cross functional execution encompassing: generating strategic plans; forecasting; market strategy; segmentation; branding; market research; product design goals; product management; competitive benchmarking and pricing.
  • Sharp business acumen, numeracy and resilience to adapt to, and enhance, new and evolving business models (for example, as required for a new decentralized diagnostic testing business).
  • In depth knowledge of the oncology marketplace, reimbursement, key trends, account segments and customer needs.
  • Exceptional communication and presentation skills.
  • Proven team player with ability to frequently and successfully collaborate cross-functionally.
  • Bachelor’s Degree is required. An MBA, or other advanced degree, is preferred.
  • Business travel is required for approximately 30% of the time.
  • Location ideally Seattle-based, or our Redwood City office

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

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Life Sciences Sales

Department: Life Sciences Sales

City: Paris

Country: France

Type: Full Time

Experience: Experienced

Job Summary:

The Technical Sales Specialist (TSS) supports our European Sales team, to addresses growth of our 3-D biology portfolio, and manages the Digital Spatial Profiling (DSP) service number.The Technical Sales Specialist (TSS) supports our European Sales team, to addresses growth of our 3-D biology portfolio, and manages the Digital Spatial Profiling (DSP) service number.

Territory:  EMEA

Essential Duties:

  • Developing 3-D Biology business in the Pharmaceutical, biotech, and academic market segments. 
  • Support the defined RAMs territories to develop and grow product portfolio
  • Support the Business Development team to identify and develop new collaboration opportunities involving the product portfolio including our DSP service.
  • Development of new business through intelligent networking and a sophisticated ability to generate new clients.
  • Managing contracts and projects for our DSP service.
  • Liaising and interacting with all business teams

Requirements:

  • A track record of delivering sales targets, exceptionally target driven and proven at developing relationships with key decision makers of all levels.
  • Management of high complexity sales with a proven understanding of the market segment.
  • Experience in negotiating high value contracts
  • Proven understanding of Pharmaceutical and biotech Research development, Biomarker discovery, genomic analysis and proteomics applications.
  • Ability to work closely with global commercial functions, including sales professionals and business development, to ensure strategic input for the direction and continued success of the business.
  • Minimum B.S. in Life Science discipline.  Ph.D. or advanced degree preferred.
  • Proven sales experience within a Life Science, Translational Research, Diagnostics, CRO capacity within the Pharmaceutical-Biotechnology industry
  • Strong technical understanding of proteomic technologies and immuno-oncology.
  • Ability to travel within Europe 75% of the time

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1


Life Sciences Marketing

Department: Life Sciences Marketing

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Experienced

Job Summary:

NanoString has a core vision to bring disruptive technologies to transform the life sciences and biopharma industries. NanoString is developing simplest and fastest clinical sequencing solution using the Hyb&Seq Platform. This position will be a part of the product marketing team responsible for strategy and development of the NGS Product Portfolio to maximize ROI and value to the company. This role includes the use of market research to add insight into defining content for clinical NGS panels. He/she defines go to market strategy and manages full menu of clinical NGS panels. 

Essential Duties:

  • Drives the strategic direction and product road map for the clinical NGS Panel portfolio to ensure alignment with commercial objectives.
  • Assess market demands and user needs and develop market entry strategies for NGS Panels.
  • Work in interdisciplinary project teams towards the development and launch of new products.
  • Develop and achieve the revenue budget for NGS Panels.
  • Leads the development and implementation of GTM plans and marketing campaigns in collaboration with the Business Unit Lead, NGS.
  • Develops appropriate sales tools, collateral, web content, and top line mass communication content based on specific audience type and goals of initiative.
  • Develops clinical portion of training materials for field sales to ensure effective communication of core messaging.
  • Communicates with Sr. leadership team on product performance, issues, or market changes.
  • Creates clear performance metrics and programs to measure effectiveness of relevant marketing efforts.

Requirements:

  • Previous experience with next generation sequencing technology is mandatory; scientific degree, PhD and/or MBA degree is a plus.
  • Min. of 3 years working experience in product management/marketing in the Life Science/Diagnostic industry.
  • Polished and engaging presenter to ensure messaging, value proposition is clear and understandable to target audience
  • Customer focused with a deep understanding and command of molecular Dx and oncology end markets. Knowledge of customer requirements and competitive offerings.
  • Ability to travel extensively (~50%)
  • Energetic, resourceful self-starter with high integrity and the ability to work effectively in a dynamic, collaborative environment.

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

Department: Life Sciences Marketing

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Mid Level

Job Summary:

The Product Manager is responsible for driving product development/enhancement programs, developing marketing strategies, promotional programs, and related activities to ensure that new and existing products meet organizational goals and expectations. This individual identifies unmet customer needs and market trends that will assist in the development of new product concepts and configurations. Then works with product development teams to create great new products or enhancements.  The individual stays informed of competitor products and maintains competitive comparisons and evaluations. Additional responsibilities include developing sales collateral and sales tools, including product profiles, brochures, specifications sheets, competitive analysis and white papers.

Essential Duties:

  • Define go-to-market strategy, develop product positioning and recommend pricing strategies to ensure the best possible performance versus business goals
  • Successfully collaborate across functional partners including R&D, manufacturing, and sales, in order to achieve business objectives
  • Identify partnering opportunities for complimentary third-party products which broaden or enhance the company's life science portfolio
  • Work with marketing communications professionals to develop programs and collateral materials for products on the market
  • Strategically evaluate new product and application opportunities and identify synergies with other products in the portfolio
  • Develop product launch strategies and implement launch plans
  • Identify partnering opportunities for complimentary third-party products to broaden company's portfolio
  • Manage financials for products, including sales revenue, cost, profit, marketing expense, and other product related expenses

Requirements:

  • Technical degree in molecular biology, biochemistry or related Life Science field
  • MBA preferred
  • 2-4 years of experience in marketing and/or product management in the Life Sciences field
  • Skilled at developing and maintaining highly effective cross functional relationships across the organization – with R&D, Product Development, Marketing and Project Management teams
  • Excellent written and verbal communication skills
  • Strong work ethic – driven to produce great work products pride in professionalism and work quality
  • The ability to work independently and assist less experienced peers when necessary
  • Ability to travel up to 30% of time

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

IND123

Department: Life Sciences Marketing

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Entry Level

Job Summary:

The Associate Product Manager provides support for maintaining, developing and launching new products for a designated product portfolio. Support includes but is not limited to working with internal and external teams to:  develop product quality documentation, maintain web content, draft marketing/training materials and perform competitor/market analysis as needed. Work closely with scientific, marcom, and business leadership teams to support and drive completion of research and commercial objectives

Essential Duties:

New Product Development Logistics and Sustaining Efforts:  

  • Support product development initiatives by providing inputs to development teams, developing product documentation, owning price updates and managing beta and early access programs, etc.
  • Perform focused marketing research projects:  requirements gathering, competitive analysis, market segmentation, pricing/margin analysis, etc.
  • Maintain product sales summaries and customer purchasing trends

Product Marketing:  

  • Assist in review/development of marketing collateral to support product lines
  • Owner ensuring all web content is current and accurate
  • Track timely execution of marketing communication activities

Sales and Field Based Support:  

  • Provide marketing support to field team for product lines
  • Support in organizing or participating in product tradeshows and conferences.

 

Requirements:

  • Technical degree in molecular biology, biochemistry or related Life Science field
  • MBA preferred
  • 1-2 years of experience in marketing and/or product management in the Life Sciences field
  • Skilled at developing and maintaining highly effective cross functional relationships across the organization – with R&D, Product Development, Marketing and Project Management teams
  • Excellent written and verbal communication skills
  • Strong work ethic – driven to produce great work products pride in professionalism and work quality
  • The ability to work independently and assist less experienced peers when necessary
  • Ability to 10-25% of the time.

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1


Manufacturing

Department: Manufacturing

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Experienced

Job Summary:

The Manufacturing Research Associate I is responsible for supporting the production of reagents used in nCounter Analysis Systems. The role requires learning and performing both manual and automated production processes for the manufacture of raw, intermediate, and final reagents needed for the multiplexed detection and quantification of many different types of target molecules from biological samples. This individual learns to use professional concepts and apply company policies and procedures to resolve routine issues, in addition to acquiring the skills to use equipment, perform SOPs, use Document Control systems, ERP systems, etc.

Essential Duties:

  • SCHEDULE: Sunday thru Thursday, Day Shift
  • Follow detailed work instructions according to process, product, and Quality System requirements
  • Collaborate with production teammates and supervisors to prioritize and schedule daily production needs
  • Work both independently and in a team environment
  • Perform Incoming QC on raw materials
  • Prepare raw materials for inclusion in finished products
  • Manufacture reagents critical to various nCounter assays and internal processes
  • Manufacture intermediates and finished products
  • Perform QC testing of intermediates and finished products

Requirements:

  • Bachelor's degree in a scientific discipline
  • 0-2 years of hands-on laboratory experience in a medical device, biotechnology, or academic setting
  • Strong analytical, organizational, documentation and communications capabilities
  • Ability to handle multiple tasks and meet defined deadlines
  • Experience in either a high-throughput or production environment (desirable)
  • Familiarity with Microsoft Dynamics NAV or other ERP/MRP system (desirable)
  • Knowledge of ISO-13485, ISO-14971 and/or QSR 21 CFR 820 (desirable)
  • Familiarity with MasterControl or other EQMS system (desirable)
  • Ability to lift and carry 20-25lb freezer/refrigerator racks
  • Willing to work a flexible shift schedule

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

 

Department: Manufacturing

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Entry Level

Job Summary:

The Manufacturing Research Associate I is responsible for supporting the production of reagents used in nCounter Analysis Systems. The role requires learning and performing both manual and automated production processes for the manufacture of raw, intermediate, and final reagents needed for the multiplexed detection and quantification of many different types of target molecules from biological samples. This individual learns to use professional concepts and apply company policies and procedures to resolve routine issues, in addition to acquiring the skills to use equipment, perform SOPs, use Document Control systems, ERP systems, etc.

Essential Duties:

  • Monday thru Friday Day Shift - Consumables Team
  • Follow detailed work instructions according to process, product, and Quality System requirements
  • Collaborate with production teammates and supervisors to prioritize and schedule daily production needs
  • Work both independently and in a team environment
  • Perform Incoming QC on raw materials
  • Prepare raw materials for inclusion in finished products
  • Manufacture reagents critical to various nCounter assays and internal processes
  • Manufacture intermediates and finished products
  • Perform QC testing of intermediates and finished products

Requirements:

  • Bachelor's degree in a scientific discipline
  • 0-2 years of hands-on laboratory experience in a medical device, biotechnology, or academic setting
  • Strong analytical, organizational, documentation and communications capabilities
  • Ability to handle multiple tasks and meet defined deadlines
  • Experience in either a high-throughput or production environment (desirable)
  • Familiarity with Microsoft Dynamics NAV or other ERP/MRP system (desirable)
  • Knowledge of ISO-13485, ISO-14971 and/or QSR 21 CFR 820 (desirable)
  • Familiarity with MasterControl or other EQMS system (desirable)
  • Ability to lift and carry 20-25lb freezer/refrigerator racks
  • Willing to work a flexible shift schedule

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1


Regulatory Affairs

Department: Regulatory Affairs

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Senior Manager/Supervisor

Job Description:

The successful candidate is responsible for assisting in guiding regulatory affairs activities for the regulatory affairs department culminating in the preparation of relevant regulatory filings to FDA and global regulatory authorities, with a particular focus on companion diagnostics.  Responsibilities will include life-cycle management of select pipeline products that are both marketed and in development, maintenance of needed registrations and certifications, and alignment of regulatory strategy with corporate strategy in conjunction with senior management.

Essential Duties:

  • Guiding regulatory affairs staff to successfully participate in product design teams
  • Creates, evaluates and updates Regulatory Affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced, and guides staff in these activities
  • Reviews labeling/promotional/advertising materials, and other documents to ensure compliance, and guides staff in these activities
  • Maintains current knowledge of relevant regulations, including proposed and final rules.
  • Interprets RA policies and guidance and correctly apply them as regulatory activities, and guides staff in these activities
  • Development, management and execution of regulatory plans for large-scale projects, including companion diagnostics, and guides senior staff in these activities, as applicable

Requirements:

  • BA/BS degree is required. Preferred education/experience include bioengineering, biological, physical, clinical and regulatory sciences. Advanced degrees (MS, MBA, PhD., etc.) a plus
  • Previous in vitro diagnostic (IVD) nucleic acid experience and/or companion diagnostic (CDx) experience highly preferred
  • 6+ years of experience in Regulatory Affairs with FDA regulated products, minimum of 2 years of successful management experience
  • Previous experience with 510(k), IDE, and/or PMA submissions
  • Good knowledge of FDA QSR and ISO 13485 regulations
  • Experience in a Molecular Biology research environment
  • Strong intellectual capacity and curiosity, and ability to digest complex technical data
  • Certifications: RAC, CQA, CQM  preferred
  • Strong interpersonal skills with the ability to influence others in a positive and effective manner
  • Strong organizational skills and ability to support multiple projects
  • Proven ability to prepare regulatory submissions and interact with FDA to obtain and maintain product approvals, and equivalent in international markets
  • Proven ability to motivate and develop junior staff

#LI-MS1

Department: Regulatory Affairs

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Mid Level

Job Summary:

The Regulatory Affairs Specialist evaluates and completes US, Canada, and EU regulatory projects consistent with the company goals. This individual is responsible for preparing regulatory submissions for the US FDA, Health Canada and the EU.   Responsibilities include acting as the regulatory representative on developmental core teams culminating in the preparation of relevant regulatory filings to the FDA or other government agencies.

Essential Duties:

  • Oversee/support regulatory projects consistent with the company goals
  • Leadership and/or assistance in creating timely regulatory document packages for submissions and registrations of new and mature products
  • Manage and maintain regulatory files based on regulatory and post-market requirements
  • Compile, coordinate, and format all materials required in submissions, license applications/amendments, technical file documentation and annual reporting
  • May have direct interaction with regulatory agencies on defined matters.
  • Contribute to the creation and execution of regulatory strategies for clinical trial applications
  • Recommend changes for labeling/promotional/advertising materials, manufacturing, marketing and clinical protocol for regulatory compliance to the appropriate regulations, as needed
  • Assist in the creation, evaluation, implementation and update of internal regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
  • Maintain awareness, excellent comprehension and appropriate application of relevant regulations including proposed and final rules.
  • Requires some supervision with latitude for independent judgment

Requirements:

  • BA/BS degree is required, preferred education/experience areas include bioengineering, physical, biological, and regulatory sciences, Advanced degrees (MS, PhD., etc.) a plus
  • Direct experience interacting/interfacing with Regulatory Agencies (e.g. FDA, Notified Bodies, and/or Health Canada, etc.)
  • 2-4 years of experience with US FDA, Health Canada and/or EU regulations at a diagnostic or a medical device company (experience may be combined with pertinent education)
  • Knowledge of US FDA, Health Canada and/or EU laws, regulations, standards and guidances that affect diagnostic products
  • Working knowledge of FDA Quality System Regulations and ISO 13485
  • Previous experience with preparing and submitting 510(k), IDE, and/or PMA, MDLA, Design Dossiers, Technical Files or other regulatory submissions and some interaction with regulatory authorities for registrations
  • Previous in vitro diagnostic (IVD) experience highly preferred -or- experience in a Molecular Biology research environment
  • Excellent communication skills; both oral and written
  • Strong interpersonal skills with the ability to influence others in a positive and effective manner
  • Demonstrated ability to contribute to a continuous learning and process improvement environment
  • Strong intellectual capacity and curiosity desired
  • Strong organizational skills and ability to support dynamic programs
  • Proven ability to work on product development teams
  • Certifications: RAC, preferred

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

Department: Regulatory Affairs

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Mid Level

Job Description:

Creates, evaluates and completes International regulatory projects consistent with the company goals. Successful candidate is responsible for assembling regulatory submissions and international dossiers to non-EU territories.

Responsibilities:

  • Oversees/supports International regulatory projects consistent with the company goals. Ensures timely registration of products in compliance with applicable regulations and guidance.
  • Responsible for implementation of regulatory strategies through coordination and preparation of submission documents for the registration of new products and changes to existing products in international markets (i.e.South/Central America, Asia) including; annual reporting, re-licensing, and change reporting. 
  • Interact with Regulatory Affairs personnel at regulatory agencies, contract manufacturers and distributors to ensure registrations are current and compliant.
  • Creates, implements and/or supports regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
  • Maintains current knowledge of relevant regulations, including proposed and final rules.
  • Interprets RA policies and guidance and correctly applies them as regulatory activities

Requirements:

  • BA/BS degree is required. Preferred education/experience areas include bioengineering, physical, biological, and regulatory sciences, Advanced degrees (MS, PhD., etc.) a plus
  • 0-2 years of experience with international medical device regulations (IVD and/or companion diagnostic experience a plus)
  • Previous experience with global regulatory filings (i.e. South/Central America, Asia)
  • Strong interpersonal skills with the ability to influence others in a positive and effective manner
  • Excellent organizational skills and ability to support multiple projects
  • Excellent verbal and written skills
  • Intellectual curiosity and an ability to digest complex technical data

Other

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

Supply Chain

Department: Supply Chain

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Mid Level

Job Summary:

The Sales Order Administrator II works with customers, the sales team, and internal departments to support sales and manufacturing order processing.

Essential Duties:

  • Support sales and manufacturing order processing
  • Respond to customer inquiries
  • Process customer orders, revise sales quotations, and enter data in our corporate ERP system.

Requirements:

  • A college education with a four-year degree (preferably in the Life Sciences)
  • 2-4 years of previous relevant experience in a customer facing role within a high tech environment, particularly within a life sciences related business
  • Previous experience in order handling using an ERP or CRM system, preferably Microsoft Dynamics NAV or Microsoft Dynamics CRM
  • Strong verbal and written communication skills, and excellent computer skills
  • Ability to multi-task in a fast paced environment while meeting the multiple needs and demands of others
  • Accuracy and attention to detail are important attributes for success in this position
  • Strong organizational skills and the ability to prioritize their work
  • Ability to work both independently and cross-functionally
  • Proficient in the use of standard software packages such as MS Excel, Word and PowerPoint

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

 

Department: Supply Chain

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Entry Level

Job Summary:

NanoString is seeking a professional Material Handler to join our Supply Chain team.  Responsibilities will include inventory management, cycle count, receipt of goods, and kitting customer orders.  Additional responsibilities could include processing domestic and international shipping orders.  This is an opportunity for a highly motivated individual capable of operating in a dynamic, fast paced environment. 

Essential Duties:

  • Accept receipt of products and ensure that materials are in good condition. 
  • Unpack and check goods received against purchase orders or invoices.
  • Operate effectively in our ERP system for goods receipts and to create and process production orders and shipments.
  • Maintain all records related to incoming goods.
  • Reject unsatisfactory items as required, and assess the need to file claims with carrier
  • Participate in weekly cycle counts, and assist with reconciliation of item variance.
  • Kitting raw materials into finished goods using Standard Operating Procedures.
  • Process customer orders through the NAV ERP system.
    • Verify inventory locations and availability for shipment against requirements specified in purchase orders.
  • Physically package all outbound shipments to domestic and international customers
  • Fulfill internal orders of consumable lab supplies and reagents
  • Fulfill internal orders of consumable lab supplies and reagents
  • Other duties as assigned
  • Ensure compliance with all state, federal, environmental, safety, and hazardous waste regulations.
  • Special project support as required.

Requirements:

  • 1-3 years of direct work experience in a warehouse environment, managing inventories and kitting customer orders. 
  • Excellent written and verbal communication skills required.
  • Prior warehouse and inventory management experience preferred.
  • Team player with proven ability to work well under pressure and constant deadlines.
  • Problem solving skills with the ability to seek alternative solutions for dilemmas and problems.
  • Strong attention to detail with excellent follow-up.
  • Working knowledge of Microsoft office Products, especially Outlook and Excel.
  • Professional aptitude, presentation and demeanor.
  • Detail-oriented
  • Can quickly learn new skills and is adaptable to rapid change.
  • Teamwork, Respect, Integrity, Innovation, and strong customer focus.
  • Ability to lift 50 lbs
  • Ability to work autonomously and adapt to change in a fast-paced environment
  • Working experience in the biotech/life science industry is preferred
  • Familiarity with an ERP system, preferably Microsoft Navision
  • Certification in powered industrial trucks (walkie-stacker, fork lift)

Other: 

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

IND123

Department: Supply Chain

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Experienced

Job Summary:

Manage supplier quality activities and drive quality and process improvement. Assess, monitor, and ensure the continued adequacy and effectiveness of Nanostring’s Supplier Quality System. Support supplier selection, supplier process validation/controls, supplier auditing, supplier corrective actions and supplier development. This position interacts with Procurement, Manufacturing, Sustaining Engineering, R&D and Quality to ensure quality of incoming materials.

Essential Duties:

  • Drive failure analysis and supplier corrective action requests (SCAR)
  • Support MRB/non-conforming material processes as well as approved vendor list (AVL) sign off procedures
  • Approve supplier manufacturing/test/inspection plans and procedures
  • Perform periodic supplier audits and risk assessments
  • Ensure the proper validation of supplier processes and test methods and the product/process change management process
  • Work closely with critical suppliers to sustain and improve component quality
  • Ensure accurate and complete preparation of supplier quality engineering documents as required, including but not limited to component qualification/process validation plans, supplier audits/approvals, incoming inspection planning, and other miscellaneous quality documentation and records
  • Support new supplier development and commodity team strategies
  • Participate in design reviews with the development teams
  • Maintain supplier key performance indicators (KPIs) and drive continuous improvement; support any score carding activities
  • Correlate and standardize test and inspection processes as required
  • Maintain 100% compliance to Nanostring processes, procedures and specifications
  • May participate in definition of critical-to-quality/process/function parameters for critical components/sub-systems
  • Other related duties as assigned

Requirements:

  • Bachelor's degree in an engineering, Life Science or equivalent combination of education and directly relevant experience
  • A minimum of 5 years of experience in a GMP and/or FDA regulated industry is required
  • Experience in the medical device and/or pharmaceutical industry is preferred
  • Operations supplier quality experience is preferred
  • Demonstrated understanding of statistical control and quality management principles
  • Knowledge of specification development, industry standards, geometric dimensioning and tolerancing (GD&T), etc.
  • ISO 13485 Auditor trained or experience with supplier auditing
  • Strong communication, teamwork, and problem-solving skills are required
  • Strong root cause analysis skills are required
  • Six Sigma, Lean, or ASQ Certification and/or trainings are preferred
  • Up to 25% travel may be required

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

IND123

Department: Supply Chain

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Mid Level

Job Summary:

The Material Handler II is responsible for inventory management, cycle count, receipt of goods, and kitting customer orders.  Additional responsibilities could include processing domestic shipping orders. 

Essential Duties:

  • Accept receipt of products and ensure that materials are in good condition
  • Unpack and check goods received against purchase orders or invoices
  • Operate effectively in our ERP system for goods receipts and to create and process production orders and shipments
  • Maintain all records related to incoming goods
  • Reject unsatisfactory items as required, and assess the need to file claims with carrier
  • Participate in weekly cycle counts, and assist with reconciliation of item variance
  • Kitting raw materials into finished goods using Standard Operating Procedures
  • Process customer orders through the NAV ERP system
  • Verify inventory locations and availability for shipment against requirements specified in purchase orders
  • Physically package all outbound shipments to domestic and international customers
  • Fulfill internal orders of consumable lab supplies and reagents
  • Manage on hand inventory and interact with purchasing to ensure sufficient inventory to meet requirements
  • Fulfill internal orders of consumable lab supplies and reagents
  • Manage on hand inventory and interact with purchasing to ensure sufficient inventory to meet requirements
  • Interact closely with Finance on all inventory related issue resolution
  • Ensure compliance with all state, federal, environmental, safety, and hazardous waste regulations
  • Special project and other duties as assigned

Requirements:

  • 2-4 years of direct work experience in a warehouse environment, managing inventories and kitting customer orders
  • Excellent written and verbal communication skills required
  • Prior warehouse and inventory management experience preferred
  • Team player with proven ability to work well under pressure and constant deadlines
  • Problem solving skills with the ability to seek alternative solutions for dilemmas and problems
  • Strong attention to detail with excellent follow-up
  • Working knowledge of Microsoft office Products, especially Outlook and Excel
  • Professional aptitude, presentation and demeanor
  • Detail-oriented
  • Can quickly learn new skills and is adaptable to rapid change
  • Teamwork, Respect, Integrity, Innovation, and strong customer focus
  • Ability to lift 50 lbs
  • Ability to work autonomously and adapt to change in a fast-paced environment
  • Working experience in the biotech/life science industry is preferred (GMP experience)
  • Familiarity with an ERP system desired, preferably Microsoft Navision
  • Certification in powered industrial trucks (walkie-stacker, fork lift) preferred
  •  

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

IND123

Department: Supply Chain

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Experienced

Job Summary:

We are seeking a Senor NPI Buyer to join our Supply Chain group. In this role you will support the development of new genomic tools that consist of instrumentation, consumables, and chemistry. In particular, this position is focused on the development of new suppliers and agreements to support the product development, prototyping and pilot production. The work is highly interdisciplinary and will involve working closely with biologists, scientists, design engineers, software engineers, supply chain, quality, legal and external OEM manufacturers to support product commercialization and partnership management.

Essential Duties:

  • Responsible for developing and executing materials plans to enable prototype builds and production ramp plans
  • Provide business process and application support throughout product development process
  • Facilitate and monitor contracts with supply chain partners
  • Own supply chain commercialization deliverables and roadmap related to vendor engagement, RFQ, supplier qualification, and production
  • Focus on continuous improvement for both the business process and the underlying technologies
  • Collaborate with cross functional teams to assure a smooth product transition from research and development to production
  • Participate in identifying, influencing, selecting and qualifying suppliers. Collaborate with internal functions and suppliers to finalize product design, material selection & process selection. Participate in assessing supplier capabilities and partnership potential
  • Facilitate the creation of commercial supply agreements to support program needs ensuring all key operations and manufacturing requirements are adequately addressed. Obtain necessary consensus by leading trade-off discussions and prioritization activities on contracts. Understands demand planning and works with internal and external teams to develop capacity plans for scale up including requirements for capital and validation expenses
  • Cultivate and maintain successful relationships between NanoString and supply chain partners
  • Build internal and external relationships through problem solving and demonstrating accountability
  • Know and apply supply chain and quality system requirements during supplier evaluation and audit

Requirements:

  • A college education with a four-year degree (preferably in Business, Supply Chain, or Engineering)
  • Minimum five (5) years of product development procurement or supply chain experience
  • Demonstrated working knowledge of end-to-end contract experience from pricing/negotiation strategies through contract administration
  • Working knowledge of ISO 13485 and FDA 21 CFR 820 quality systems
  • Intermediate to advanced Microsoft Excel skills required (ie. complex functions)
  • Experience creating and delivering PowerPoint presentations to multiple organization levels, including leadership
  • Experience in validated medical device manufacturing environment is preferred
  • Supplier audit experience is preferred
  • The ability to work independently and cross-functionally
  • This position requires a highly motivated individual with strong analytical skills, intellectual curiosity and proven leadership skills
  • This position may require up to 15% domestic and international travel

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

Department: Supply Chain

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Experienced

Job Summary:

The Senior Planner Buyer is responsible for the materials planning and procurement functions to support NanoString’s products and services by maintaining the appropriate supply of qualified materials. S/he will be accountable for creating BOMs, managing the Sales and Operations Planning process, generating and updating product forecasts in MRP, contract negotiations, supplier selection, establishing inventory re-order points and creating the purchase orders necessary to effectively manage supply.

Essential Duties:

  • Coordinate cross-functional input to update forecast using the Sales and Operations Planning process. Interact with Sales, Marketing and other internal customers to understand demand forecast drivers.
  • Review historical sales trends and prepare forecast data to evaluate forecast variances versus actual demand.
  • Update ERP system (Microsoft Navision) with timely and accurate item level planning
  • Monitor and report inventory levels (Raw, WIP and Finished Goods). Perform planning to ensure overall inventory is at optimal levels including consumption of obsolete/slow moving inventory at multiple sites.
  • Provide meaningful inventory reporting and analysis that interprets data and communicates information for decision making.
  • Evaluate and make recommendations to the overall planning process consistent with continuous improvement goals.
  • Ensure the timely incorporation of engineering change orders (ECOs) that affect ordering, scheduling, and inventory levels.
  • Perform non-obsolescence planning including monitoring end-of-life status of components and subassemblies
  • Ensure that spares inventory and spares demand on the production organization are aligned with spares and retrofit sales projections and net inventory and inventory turns budgets established by the business.
  •  Maintain partnerships with key internal customer (operations, product development, finance, legal, and quality) to assure awareness of developing and projected key projects & business needs that will affect the supply base needs (technology, quality, capacity and capabilities).
  • Support and achieve targeted product launch and/or revision dates.
  • Tactical execution of orders and fulfillment in collaboration with Supply Chain and Quality.
  • Effective management of standard costs and purchase price variance. Proactive generation of savings/efficiency opportunities, thorough due diligence, and effective implementation.
  • Effective negotiation and development of supply contracts and ongoing management of addendums, revisions, extensions and notifications.
  • Support departmental key performance indicators and adapt new indicators as needed.
  • Conduct spend analysis and sourcing plans to continuously add business value and enable achievement of financial goals.
  • Effective “Supplier Relationship Management” for strategic and critical suppliers, including business relationship, performance management, collaboration, strategic planning, cross-functional topics and participation, key internal customers and formal business and performance review meetings. 
  • Search and locate supplier options as required to achieve commercial and strategic objectives.

Requirements:

  • Bachelor’s degree required, preferably in business, engineering or supply chain; CPIM, CSCP or CPSM certification preferred.
  • 8+ years’ experience in a related field, including purchasing, supply chain, or business with sourcing, supplier relationship management and contract development required.
  • Experience in biotech/life sciences industry, and FDA regulated environments preferred.
  • Experienced user of ERP system.
  •  Analytical skills to support strategic and tactical activities and analysis.
  • Negotiations and contract development experience.
  • Demonstrated flexibility and responsiveness as needed for the consumer business
  • Collaborate effectively with peers, stakeholders and partners across the organization.

 

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

IND123


Human Resources

Department: Human Resources

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Entry Level

Job Summary:

The HRIS Analyst I is responsible for report generation, data entry, data integrity, and on-going maintenance tasks for the Human Resource Information Systems (HRIS).   This role will work with multiple systems and tools to create, update, analyze and report on employee data.  This role will prepare and provide to payroll all necessary data input and documentation to meet multiple pay cycle deadlines.  This role will also support HR and other end-users in use of the systems and tools.  This role will also act as a back-up to other HR roles and be involved in multiple ongoing initiatives.   

Essential Duties:

  • Create custom and ad hoc reports as needed by internal and external customers.
  • Run scheduled reports for end users and outside functions.
  • Responsible for day-to-day, ongoing maintenance and process tasks within the HRIS system including import loads, accrual adjustments, creating new locations, etc.
  • Assist with support questions from end users.
  • Maintain employee database ensuring data integrity for the HRIS system through security and audit reporting.
  • Support and participate as a project team member in ongoing HRIS and other system implementation projects.
  • Support and participate in the necessary upgrades or changes for HRIS system.
  • Assist with training end users.
  • Back up other HR positions as required.

Requirements:

  • Minimum of 1 year of experience involving extensive data reporting/analysis or database management.
  • HRIS experience required, preferably with ADP.
  • Bachelor’s degree in HR, IT, or related field.
  • Prior experience developing and generating reports & analytics; ability to analyze data and metrics to identify trends and areas of opportunity.
  • Strong knowledge of MS Office to include: advanced knowledge of Word, advanced Excel capabilities (formulas, pivot tables, macros) to include proficiency in spreadsheet analysis; solid Access database and intermediate PowerPoint skills. Strong technical aptitude required.
  • Basic SQL report writing skills preferred.
  • Excellent communication skills necessary in determining report requirements for internal customers.
  • This position requires the ability to work in a fast-paced, team-oriented confidential environment and exceptional attention to detail.  Strong focus on confidentiality is a must.

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

Department: Human Resources

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Experienced

Job Summary:

We are growing and evolving quickly and need a talented Recruiter to help us through this intense period. Looking for full cycle recruitment experience and must be willing to work onsite in South Lake Union. Initial commitment will be 3 months and depending on level of hiring activity, could certainly go longer. 

Requirements:

  • 2-10 years in-house recruitment experience
  • Biotech or other fast pace industry (tech, healthcare, etc) experience
  • Experience with ATSs
  • Extra bonus: someone who has helped implement a new ATS
  • Incredible commitment to superior candidate and internal customer experience
  • AVAILABLE to start within 1 week

Hourly Rate is negotiable and you will be payrolled via a local agency (not payrolled by NanoString)

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1


Quality Assurance

Department: Quality Assurance

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Executive

Job Summary:

The Senior Director/Director, Quality Assurance, reporting to the Vice President of Quality Assurance and Regulatory Affairs, in conjunction with executive management and Regulatory Affairs, develops strategic and tactical plans to ensure compliance with national and international quality management system requirements. This individual has overall responsibility for maintenance and continuous monitoring and improvement of the Company's Quality Management System, in conformance with ISO-13485, FDA's QSR/GMP requirements, and any other applicable regional in vitro diagnostic regulations.

Essential Duties:

  • Lead and develop the Quality Assurance team which comprises:  Quality Assurance, Change Control and Quality Engineering.
  • Develop and Implement a Quality Strategic Plan for supporting Life Sciences, RUO, and Diagnostic medical devices.
  • Maintain ISO-13485 registration.
  • Ensure on-going compliance with FDA's QSR/GMP requirements and any other applicable regional in vitro diagnostic regulations.
  • Serve as the primary point of contact with the Company's notified body/external auditor
  • Drive continuous monitoring and process improvements.
  • Partner with cross-functional leadership to ensure all aspects of Product Development and Delivery are performed in conformance to the quality management system and regulatory requirements.
  • Improve customer satisfaction through Quality initiatives and process improvement.

 

Requirements:

  • Undergraduate or advanced degree (B.S., M.S., or Ph.D.) in a Life Science.
  • A minimum of ten (10) years of experience implementing and/or maintaining quality management systems in an FDA GMP or ISO-13485 regulated industry setting.
  • At least seven (7) years of management experience in a medical device company (class II or class III) with both domestic and international products.
  • In-depth knowledge of and experience with ISO-13485, ISO 14971, GMP/GLP, QSR, 21 CFR 820.30, and other medical device (IVD) regulations.
  • Experience building and leading high performing teams, including direct-report managers.
  • Proven ability to lead cross-functional teams in problem-solving and continuous process improvement.
  • Experience with medical device (IVD) software, hardware and reagent development.

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

Department: Quality Assurance

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Manager/Supervisor

Job Summary:

The Manager, Quality Engineering, reporting to Sr. Quality Management, will provide quality leadership and guidance responsible for consistent implementation, improvement and compliance to the NanoString Quality System and global regulatory requirements including, but not limited to: FDA (§21 CFR 820, ISO13485, Canadian Medical Device Regulatory (CMDR), and In Vitro Diagnostic Directive (98/79/EC). This role provides technical, quantitative, and coordination support to ensure products and processes are designed, deployed, and operate according to controlled specifications and requirements.

Essential Duties:

  • Supports collaborative quality input and guidance to NanoString teams to ensure applicable processes and products comply with NanoString policy and procedures.
  • Leads and implements policies and procedures supporting a QSR-compliant Quality System. Emphasis will be placed on critical quality elements (Product Development (Inputs/Outputs), Design Controls, Design Transfer, Design Specifications, Risk Management, Manufacturing, and Quality Control processes and procedures.
  • Guides development and review of Design Transfer activities to include verification/validation of reagent specifications, documentation of manufacturing procedures, verification/validation of inspection requirements for receiving materials and QC tests for in-process and final product materials, definition of product kit component labeling specifications, and successful completion of process validation.
  • Ensures Design Transfer procedures to Contract Manufacturers (CM) follows compliant policy and procedures.
  • Leads a quality team in the gap analysis of controlled Design History File and Device Master File for all products.
  • Issue, review, and maintain quality records for all deviations resulting in non-conformances and NCMR.
  • Review customer complaints collaboratively with Technical Support and Instrument Services sustainability teams; ensure SCAR or CAPAs are issued and investigated, as needed.
  • Develop, implement, review, and improve Quality System procedures as needed.
  • Analyze company data, including customer complaints and non-conformance material reports (NCMRs), for patterns or trends; identify potential problems before they occur; seek out ways to ensure continuous improvement across the organization and all functional areas; identify root cause(s) of problems or concerns and coordinate appropriate response(s)

Requirements:

  • BS in Life Science or Engineering discipline, BME or Ph.D. preferred
  • At least 5 years of experience in the medical device or biotechnology industry
  • At least 1 year of managerial experience
  • Working knowledge of FDA Quality System Regulations (QSR), ISO 13485 and ISO 14971
  • Proven ability to technically prepare and review process validation, failure investigations, non-conforming materials, CAPA and risk assessment protocols and reports
  • Working knowledge of statistical techniques
  • Proven experience in in vitro diagnostic field required
  • Proven ability to technically prepare and review process validation
  • Working knowledge of nucleic acid assay development
  • Ability to Support CAPA and Complaint investigations
  • Ability to train others in quality processes and procedures
  • ASQ certified or CQE preferred
  • Certified Auditor preferred

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1


Department Name

Department: Department Name

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Experienced

Job Summary:

Nanostring is on the verge of commercializing a cutting-edge platform called the Digital Spatial Profiler designed to extract spatially resolved RNA and protein information from tissue samples. To this end, Nanostring is seeking an Associate Application Product Manager to manage the Technology Access Program and support commercialization of applications on the Digital Spatial Profiling platform. The ideal candidate would have a strong technical background and experience in working with key opinion leaders from biopharma and key academic centers.

The Associate Application Product Manager will work closely with the pathology services team, technical sales specialists, product application scientists, and product management to ensure successful execution of the technology access program. Moreover, the associate product manager will support key initiatives around identifying and commercializing applications related to the Digital Spatial Profiler.

Essential Duties:

Manage Technology Access Program: Onboard new client projects, ensure internal alignment around project scope, and ensure on time completion of client's projects.

Launch new capabilities: Establish strategy for commercializing new capabilities and applications through the Technology Access Program.

Marketing: Provide support in generating content for outbound marketing.

Client KOL network: Manage an active network of clients to support fee for service and collaboration projects.

Market Research: Provide support in generating appropriate market data to support application development.

Requirements:

  • Minimum degree in Life Sciences (BSc)
  • Preferred advanced degree in Life Sciences or Business (MSc, PhD, or MBA)
  • >3 years of experience in technology development and/or commercialization
  • Self-motivated, highly organized, and meticulous in details
  • Must be able to work independently, manage multiple projects, communicate proactively, and prioritize daily tasks
  • Ability to travel >30%

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

Department: Department Name

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Experienced

Job Summary:

The Custom Order Processor I is responsible for a wide range of administrative tasks involved in accurately and efficiently processing custom orders, and in identifying and implementing process improvements.

Essential Duties:

  • Track and reconcile custom orders
  • Accurately and efficiently enter data in ERP system, process custom orders
  • Maintain accurate manufacturing spreadsheets
  • Interact effectively with sales staff, sales order administration team, and other internal departments
  • Verify accuracy and completeness of orders as well as adherence to established policies
  • Proactively research questions and issues relating to orders and follow up as necessary
  • Complete special projects as needed

 

Requirements:

  • A college education with a four-year degree or a two-year degree with a minimum of two years of relevant experience
  • Minimum of 2 years of experience as an order processor
  • Previous experience in customer facing role within a high tech environment is preferred, particularly within a life sciences related business
  • Strong verbal and written communication skills
  • Excellent computer skills, including proficiency in the use of standard software packages such as MS Excel, Word and PowerPoint
  • The ability to multi-task in a fast paced environment while meeting the multiple needs and demands of others
  • Accuracy and attention to details are important attributes for success in this position
  • Strong organizational skills, the ability to prioritize work and to be able to work both independently and cross-functionally
  • Previous experience in order handling using NAVISION is a plus

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

IND123

Department: Department Name

City: Seattle

State: WA

Country: United States

Type: Full Time

Experience: Experienced

Background:

Nanostring is seeking a Senior Product Manager to lead the development and commercialization of the instrument and software for a brand new platform called the Digital Spatial Profiler (DSP). This is a “First-to-Market” technology designed to disrupt the market and create new scientific insights. The ideal candidate will have strong product management experience, demonstrated leadership skills and a bold appetite to redefine the market.

Job Summary:

The Senior Product Manager is responsible for driving product development/enhancements programs, developing marketing strategies, promotional programs, and related activities to ensure that new and existing products meet organizational goals and expectations. This individual identifies unmet customer needs and market trends that will assist in the development of new product concepts and configurations, then works with product development teams to create great new products or enhancements. The individual stays informed of competitor products and maintains competitive comparisons and evaluations. Additional responsibilities include developing sales collateral and sales tools, including product profiles, brochures, specifications sheets, competitive analysis and white papers.

Essential Functions:

  • Define go-to-market strategy, develop product positioning and recommend pricing strategies to ensure the best possible performance versus business goals
  • Successfully collaborate across functional partners including R&D, manufacturing, and sales, in order to achieve business objectives
  • Identify partnering opportunities for complimentary third-party products which broaden or enhance the company's life science portfolio
  • Work with marketing communications professionals to develop programs and collateral materials for products on the market
  • Strategically evaluate new product and application opportunities and identify synergies with other products in the portfolio
  • Develop product launch strategies and implement launch plans
  • Identify partnering opportunities for complimentary third-party products to broaden company's portfolio
  • Manage financials for products, including sales revenue, cost, profit, marketing expense, and other product related expenses

Qualifications and Requirements:

  • Technical degree in molecular biology, biochemistry or related Life Science field
  • Extensive experience in immuno-histochemistry (IHC), in situ hybridization, and/or pathology research preferred
  • Experience in commercializing instruments and software
  • MBA/PhD preferred
  • At least 5 years of experience in marketing and/or product management in the Life Sciences field
  • Skilled at developing and maintaining highly effective cross functional relationships across the organization – with R&D, Product Development, Marketing and Project Management teams
  • Excellent written and verbal communication skills
  • Strong work ethic – driven to produce great work products pride in professionalism and work quality
  • The ability to work independently and assist less experienced peers when necessary
  • Ability to travel up to 30% of time

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

#LI-MS1

IND123