Principal Design Assurance Engineer

Lead design assurance for new hardware and electrical medical device products, ensuring compliant transfer into manufacturing. Maintain Design History Files (DHF) and design risk management documentation, and serve as a technical bridge between Design Engineering and Quality. Support post-market sustaining activities including failure analysis, design changes, supplier performance, and complaint investigations. Drive design verification/validation, root cause and corrective actions, and provide subject-matter expertise in design controls, risk management, and regulatory standards.