Sr. Risk Management Engineer
Core
Ensuring product safety for medical devices by applying the risk management process throughout the product life cycle.
Role type
Senior Risk Management Engineer (Medical Devices)
Builds
Risk analysis and reduction measures for medical and medicinal devices
Domain
Healthcare / Medical Device Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management process execution, FMEA methodology, statistical methods, scientific writing, regulatory knowledge (US MDR, EU MDR, MDSAP), ISO standards (13485, 14971, Q10, GMP, 21 CFR), TrackWise, QTRAK, PDM systems (PTC, Windchill), requirement management
Preferred skills
Experience in R&D or Regulatory Affairs, experience with non-medical active or digital devices
Technologies
TrackWise, QTRAK, PTC Windchill, FMEA tools
Responsibilities
Plan and execute system risk management processes, specify risk reduction measures in cooperation with the Value Stream, maintain risk analysis for assigned devices in compliance with standards
Seniority
Senior, hands-on IC