Job ID: 7580
Job Title: Senior Design Assurance Engineer
Location: Marlborough, MA
Our client is a trailblazer in the medical device industry, dedicated to developing next-generation medical products powered by cutting-edge laser technology. With a mission to make the world a better place, they are revolutionizing healthcare by delivering innovative laser solutions that enhance patient outcomes and improve quality of life. Combining state-of-the-art engineering with a passion for innovation, the company is at the forefront of creating advanced medical devices that set new industry standards. Their dynamic and collaborative environment fosters creativity and drives continuous improvement, ensuring their products remain at the pinnacle of medical technology.
Be a part of a company where innovation meets purpose—and help shape the future of medical technology.
Position: As the Senior Design Assurance Engineer for medical laser products, you will ensure that the products meet regulatory and quality requirements throughout the design and development process. This involves collaborating with cross-functional teams to verify and validate the design outputs against user needs and regulatory requirements.
Responsibilities:
- Conduct product design control activities for new and sustaining product development efforts.
- Support risk analysis activities, including design and process FMEA.
- Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities.
- Support Design Engineering in the creation of Design History and Technical Files.
- Interact with third-party test houses that conduct compliance testing.
- Assist the regulatory department with FDA, CE, and other regulatory submissions.
- Perform all other essential duties as assigned.
Requirements:
- Bachelor’s Degree in scientific or engineering field; electrical engineering is preferred.
- 8 years minimum experience in an engineering or quality role in the medical device industry
- 3-5 years of experience with engineering and development of Class II electro-mechanical medical devices.
- Knowledge of Design Controls and Risk Management practices, regulations, and standards, such as FDA QSR’s, ISO 13485, ISO 14971, IEC 60601, 60825, 62366, and 62304 is preferred.
- Hands-on experience with Programmable Electro-mechanical Medical Systems (PEMS), New Product Development (NPD), and New Product Introduction (NPI).
- Supporting medical device compliance testing (e.g. EMC, EMI, IEC) with external test houses, such as TUV an Intertek.
- Maintenance of technical design documentation, such as design specifications, verification/validation protocols, and DFMEA/PFMEA.
- Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power, and sample size determinations, etc.), including statistical software tools, such as Minitab, is preferred.
- Experience with lasers and optical technologies is desired but not necessary.
- Strong working knowledge of Microsoft Word and Excel.
