Manufacturing Engineer II
Become a Part of the Spatial Biology Revolution
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!
The Mechanical/Sustaining Engineer II works closely with R&D, Instrument Service, and Field Applications Specialists to identify and quickly resolve any issues with the design or functionality of the NanoString product lines. This individual is part of the driving force to quickly and effectively perform root cause analysis, and to identify and carry out the necessary engineering fix for the issues. Key to the role is the timely and appropriate response to urgent matters, the ability to apply sound judgment to problem resolution, management of the engineering change pipeline, and the escalation of issues to the management level and others in the organization when appropriate.
• Own the creation and execution of all engineering change orders (ECOs), including any and all supporting documentation, 3D CAD, and engineering drawings to support any changes to product.
• Responsible for ensuring execution of corrective actions, ongoing quality improvements, and change control activities
• Drive CAPAs, NCRs, deviations, and other quality events relating to ECO activity in collaboration with the Quality team
• Support external contract manufacturers/suppliers product end of life (EOL) cycles as well as coordination of repair and refurbishment activities
• Participate in the optimization of product sourcing options, component and build costs, and manufacturing strategies
• Lead efforts to address and resolve sustaining engineering issues with internal and external customers
• Participate in evaluating new suppliers and contract manufacturers. Lead strategies for continuous cost and quality improvement programs
• Proactively support Operations in company growth and improvement efforts. Lead and implement first article inspections and quality tests
B.S and or M.S. in Electrical Engineering or Mechanical Engineering.
2-4 years of experience working for a fast-paced manufacturing environment, ideally in the medical device industry with a strong understanding of FDA regulations and experience working under FDA guidelines.
Proven track record of working with SolidWorks CAD software and Enterprise Product Data Management (EPDM) systems.
Experience working within an enterprise document control system.
Knowledge of microfluidic systems and micro-fabrication techniques.
Experience with statistical analysis of complex data sets and design of experiments (DOE).
Familiarity with these engineering principles:Injection molding
Purchased fluidics components
Purchased optical components
Optical (excitation and fluorescence)
Knowledge of quality control principles, business processes, management systems and common software applications.
Analytical and creative problem-solving skills.
Excellent communication skills, ability to clarify issues and reach consensus with an audience.
Ability to listen and understand customers’ and others’ issues and concerns, both technical and operational.
Ability to set goals for the team and achieve scheduled deadlines.
Ability to work independently and collaboratively.
Ability to work in an entrepreneurial environment with limited resources; ability to multi-task and take a creative approach to problem-solving.
Experience working within an ISO 9001 or ISO 13485 quality system.
Proficient in the use of MS Office.
Demonstrated problem-solving skills in a complex environment and in complex situations.
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.
COVID-19 VACCINATION REQUIREMENT: NanoString has a COVID-19 vaccination policy that applies to ALL U.S. employees (regardless of work location), onsite contractors and visitors except as prohibited by applicable law. As a condition of employment, newly hired employees are required to provide proof of full vaccination within 31 days of their hiring date or have applied for an exemption for which an accommodation can be made. Being fully vaccinated means that an individual is at least two weeks past their final (or only) dose of an authorized COVID-19 vaccine regimen. Exemptions will be considered for medical conditions/disabilities and sincerely held religious beliefs, observations, or practices. For any visitor coming onsite to one of NanoString’s facilities, we must verify that the visitor is fully vaccinated against COVID-19 prior to site entry and visitors must don a face mask at all times when onsite in a NanoString facility.
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