Vacancy expired!
- Products Supported - Permanently implanted heart repair and treatment devices. Occluders, delivery devices, surgical & transcatheter heart valve products plus accessories.
- Lead high visibility product development quality engineering initiatives. Emphasis on design control file gap assessments and remediation activity for EU MDR products. This is an individual contributor role on an engineering team.
- Perform EU MDR gap assessments for assigned products. Analyze and evaluate product/customer risks (UFMEA, DFMEA and Hazard Analysis). Review CAPAs, deviations and non-conformance reports to understand issues and judge appropriateness of outcomes. Partner with R&D to create/execute new protocols and reports (test methods, design verification, design validation, etc). Populate GSPR documentation (General Safety and Performance Requirements). Collaborate with other functional groups as necessary to ensure timely and accurate EU product submissions.
- Understand design control procedures and development processes. Be able to identify/create technical documentation to show evidence of compliance. Navigate Design History Files and supporting documentation evidence.
- Bachelor's degree in engineering discipline.
- Demonstrated ability to author protocols, reports, and technical justifications (TMV/DV/Design Validation/OQ/PQ/PPQ).
- Medical device industry background.
- Test method validation, design verification and validation, OQ/PQ/PPQ reports.
Vacancy expired!