Position: Product Engineer
Location: Norwood, MA
Duration: 12 months (Extendable)
Senior Risk Management Engineer - Performs complex analysis on risk management files. Facilitates cross function risk management sessions, updates risk management plans, reports and Hazard Analysis. Responsible for global procedure updates. Will be responsible for new IVDR requirements.
BS or MS in engineering degree, biomedical desired.
FMEA, HA, FTA experience and training
8 years experience in Risk Management
Expert knowledge of ISO 14971 and risk management in IVDD, IVDR
Experience with multiple projects.
Medical device experience highly desired.
Demonstrated experience driving a successful Risk Management Process.