Who We Are:
NanoString Technologies (NASDAQ: NSTG) is a leading provider of life science tools for discovery and translational research. The company’s nCounter® Analysis System is used in life sciences research and has been cited in more than 3,800 peer-reviewed publications. The nCounter Analysis System offers a cost-effective way to easily profile the expression of hundreds of genes, proteins, miRNAs, or copy number variations, simultaneously with high sensitivity and precision, facilitating a wide variety of basic research and translational medicine applications. The company’s GeoMx® Digital Spatial Profiler enables highly-multiplexed spatial profiling of RNA and protein targets in a variety of sample types, including FFPE tissue sections. Built on pioneering principles in 2003, NanoString is blazing new trails and exploring new frontiers to adapt to the everchanging landscape and becoming smarter and more innovative in the process. We are dedicated to advancing scientific discovery and providing solutions that can have a meaningful impact in research and discovery.
Our purpose is to Map the Universe of Biology. We enable scientists to answer questions they have always wanted to ask to explore the boundaries of cellular structures and create an atlas of biological interactions that define life. We are relentless in our quest to Catalyze the Next Biological Revolution leading to Advancing the Human Condition. In addition to a pioneering spirit, we value: Grit. Authenticity. Ambition. Ingenuity. Customers. Join our team!
As we develop powerful data analysis tools, cloud-based software, and systems infrastructures, we are delivering on the promise of discovery and translational science. As a Senior Software Quality Engineer, you are joining a passionate Quality Engineering team to support the product development activities of software features and product infrastructure, while working with cloud technology, serverless computing, distributed platforms, and more. This includes collaboration with cross functional teams and effective communication at multiple hierarchal levels both internal facing and with external vendors. This individual is a team player participating on core project teams to provide guidance in design controls, vendor related activities for development and own product risk management. This includes working among cross functional teams with a sharp focus on product quality throughout the lifecycle of the product.
- Collaborate with project teams as a core team member to ensure work products comply with the RUO Product Development Process, acceptable qualitative and quantitative criteria and guidance.
- Ensure test automation and regulatory compliance are embedded into software development practices and apply Lean/Agile principles in activities you participate in for the continuous improvement of how our teams function and the quality of the products we build.
- Lead and facilitate Risk Management activities during product development as well as product lifecycle, and maintain the Risk Management File (RMF, RMP, HA, FMEAs, RMR).
- Collaborate in major efforts to resolve complex technical and Quality-related problems during development and sustaining engineering for our cloud platforms.
- Determine and pursue courses of action necessary to obtain desired results through consultation and agreement with others rather than by formal review of superior.
- Collaborate in the design verification and design validation plans for new product development in conjunction with a cross-functional team.
- Review and approve project deliverables (e.g. plans, requirements, specifications, protocols, test results, traceability matrices, design reviews, reports, etc.).
- Facilitate the resolution of product related issues and root cause analysis.
- Interface with Purchasing and Engineering for supplier related product issues
- Review and approve Engineering Change Orders/Requests.
- Will perform other related duties as assigned.
- BS, MS or PhD in Life Sciences, Biomedical, or Software Engineering.
- Engineering discipline with a minimum of 5 years of experience in a regulated (pharmaceutical, medical device, IVD, aerospace, or automotive industries) or tech/biotech industry with cloud technology.
- Strong technical knowledge to ensure quality in new product development and product lifecycle.
- Experience with working on the cloud required. Next Generation Sequencing (NGS) experience preferred.
- Strong knowledge and ability to perform risk assessment and maintain risk management files (particularly software FMEAs).
- Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.
- Ability to represent the department in frequent inter-organizational and outside vendor contacts.
- Working knowledge of Quality Systems from design control to release of finished product, including, GMP, GDP, ISO 13485ISO 14971, and ISO 62304 preferred. Knowledge of FDA 21 CFR part 820 a plus.
NanoString is an Equal Employment Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. NanoString does not accept unsolicited agency resumes and will not pay fees to any third-party agency or company that it does not have a signed agreement with.
If you require assistance or accommodation when applying for open positions please contact firstname.lastname@example.org.