Senior Engineer, Design Assurance
Core
Provide critical quality engineering support throughout the product lifecycle to ensure medical device designs remain safe, effective, compliant, and aligned with user needs.
Role type
Senior Design Assurance Engineer
Builds
Medical device monitoring technologies (sensors, patient monitors, automation solutions)
Domain
Medical technology / Life sciences / Diagnostics
Required skills
Design controls, Risk management (ISO 14971), Validation & Verification (V&V), Design History File (DHF) management, Root cause analysis, GD&T interpretation, Test Method Validation (TMV/Gage R&R), Regulatory compliance (FDA 21 CFR Part 820, ISO 13485)
Preferred skills
Six Sigma Green Belt, Certified Quality Engineer (CQE)
Technologies
Microsoft Office
Responsibilities
Manage and maintain the Design History File (DHF); Perform routine DHF audits; Review and approve design requirements and changes; Collaborate on risk management files; Review and approve Test Method Validation protocols; Monitor post-market feedback and generate PMS Reports.
Seniority
Senior, hands-on IC