Senior Design Assurance Engineer

As a Senior Design Assurance Engineer for medical laser products, you will be responsible for ensuring that the products meet regulatory and quality requirements throughout the design and development process. This involves collaborating with cross-functional teams to ensure that the design outputs are verified and validated 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.
• 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.

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