Sr. Design Quality Engineer
Core
Primary QA owner driving design quality activities across the product lifecycle for medical devices, ensuring compliance with design controls, risk management, and regulatory requirements.
Role type
Senior Design Quality Engineer (Medical Devices)
Builds
Medical device products with embedded software
Domain
Medical Devices / Software Engineering
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Design controls, Risk management, Verification and validation, IEC 62304, FDA guidance, eQMS management, Test method validation, FMEA, Hazard analysis
Preferred skills
Startup environment experience, Fast-paced product development
Technologies
eQMS, Software validation tools
Responsibilities
Execute QA activities per regulations and standards, Support design control deliverables, Manage eQMS records, Author V&V protocols and reports, Conduct risk management activities, Collaborate on cross-functional design control execution, Support QMS compliance and audit readiness
Seniority
Senior, hands-on IC
