Senior Design Assurance Engineer

IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.

Our mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged, diverse, and thriving workforce that drives a sustainable future for our company and society.

Working at IPG Medical Group you can expect challenging projects, a motivating and friendly environment, and competitive benefits.

Responsibilities:

• Provide quality and compliance input to project teams for decisions and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling).
• Support Risk Management planning, updating and maintenance of the product risk documentation in compliance with regulatory standards.
• Support Usability Engineering and planning documentation
• Support the implementation of effective quality assurance, process controls, statistical analyses, and metrics.
• Provide key quality trending information and data
• Offer quality and compliance input for post-market activities such as design changes, supplier auditing, and customer complaint investigations.
• Identify, prioritize, communicate, and resolve quality issues.
• Lead implementation activities for post-market surveillance, product feedback, and corrective and preventive action programs.
• Support internal and external audits.

Education requirements

• Bachelor's Degree in scientific or engineering field

Experience requirements

• 8 years minimum experience in an engineering or quality role in the medical device industry
• 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
• 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 desired, but not necessary

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