Design Assurance Engineer

Our client is a leading innovator in medical device technology, specializing in advanced laser-powered solutions that enhance patient care. With a commitment to cutting-edge innovation and excellence, they push the boundaries of medical advancements to improve healthcare outcomes. Join a company where innovation meets purpose and help shape the future of medical technology.

Position Summary: The Design Assurance Engineer will play a critical role in ensuring product quality and regulatory compliance through robust design control and risk management practices. This position will support new and sustaining product development efforts, collaborating cross-functionally to maintain the highest medical device design and safety standards.

Join a team where startup-style medical device growth is backed by the resources and stability of an established global technology leader and help shape the future of medical technology.

Responsibilities

• Conduct product design control activities for both new and sustaining product development efforts.
• Support risk analysis activities, including design and process FMEA.
• Support Process/Design Validation and Verification activities, including software validation and IQ/OQ/PQ processes.
• Maintain technical design documentation, including design specifications, verification/validation protocols, and DFMEA/PFMEA.
• Support Design Engineering in the creation of Design History Files and Technical Files.
• Interact with and coordinate with third-party test houses that conduct product 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 a 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, including FDA QSRs, ISO 13485, ISO 14971, IEC 60601, IEC 60825, IEC 62366, and IEC 62304, is preferred.
• Experience supporting medical device compliance testing (e.g., EMC, EMI, IEC) with external test houses, such as TUV and Intertek.
• Experience maintaining 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 analysis, tolerance interval analysis, power and sample size determinations) and 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.