Engineer IV/Complaint Analysts
Core
Engineer IV leading engineering operations for medical devices, managing complaint investigations, and supporting design verification and risk management.
Role type
Senior IC medical device engineer (complaints & design)
Builds
Medical devices and combination products
Domain
Healthcare / Medical Devices / Quality Engineering
Required skills
Root cause analysis, risk management, regulatory compliance, design verification, laboratory evaluation, technical writing, project management, CAPA management, statistical analysis, mechanical/electrical engineering knowledge
Preferred skills
Experience in regulated laboratory/quality environment, Computer-Aided Design tools, prototype testing, mathematical modeling
Technologies
eQMS, Computer-Aided Design tools
Responsibilities
Receive, log, and triage customer complaints and returned devices; Coordinate and perform laboratory evaluation of returned product; Document complaint handling activities end-to-end; Determine complaint outcomes and support reportability assessments; Initiate and support CAPA and nonconformance records; Lead project technical workstreams and act as a technical SME; Perform design and test activities related to the product and manufacturing process; Develop statistically sound design verification protocols.
Seniority
Senior, hands-on IC with leadership of small teams