Design Assurance Engineer, Medical Device

Onsite Position Located in MA

My client seeks a Design Assurance Engineer for Class II electro-mechanical medical devices. In this role, 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 of IPG products.
• 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.
• 2-5 years of experience with engineering and development of Medical Devices,
• Class II electro-mechanical medical devices experience preferred.
• Knowledge of Design Controls and Risk Management practices, regulations, and standards, such as FDA QSR’s, ISO 13485, ISO 14971, 60825, 62366, and 62304, is preferred.
• Supporting medical device compliance testing (e.g. EMC, EMI, IEC) with external test houses, such as TUV and 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 desired but not necessary.
• Strong working knowledge of Microsoft Word and Excel.

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