Engineer IV/Complaint Analysts
Core
Lead engineering operations and manage complaint investigations for medical devices and combination products, ensuring regulatory compliance and product safety.
Role type
Senior IC medical device engineer (complaints & design verification)
Builds
Medical devices and combination products
Domain
Medical devices / Regulatory Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
root cause analysis, risk management, design verification, regulatory compliance, technical writing, laboratory evaluation, CAPA management, statistical analysis, mechanical/electrical engineering knowledge, prototype testing, CAD tools
Preferred skills
experience in regulated laboratory/quality environment, advanced project management, cross-functional collaboration
Technologies
eQMS, CAD tools
Responsibilities
Receive, log, and triage customer complaints and returned devices; perform laboratory evaluation and root cause analysis; document activities in eQMS; determine complaint outcomes and support reportability; initiate and support CAPA records; lead project technical workstreams; liaise with external partners on technical issues; perform design and test activities; develop design verification protocols.
Seniority
Senior, hands-on IC with project leadership
