Risk Management (Medical Devices)
Core
Conduct technical reviews and development of risk management deliverables (PHA, BE CT CHA, RMP, FMEA) for medical device programs, ensuring alignment with systems engineering and regulatory standards.
Role type
Senior Risk Management Subject Matter Expert (Medical Devices)
Builds
Risk management documentation and analysis for medical device development programs
Domain
Medical Devices / Regulatory Compliance / Systems Engineering
Required skills
ISO 14971, ISO 11608, IEC 60601-1, Hazard Analysis and Risk Assessment (HARA), Failure Mode and Effects Analysis (FMEA), Systems Engineering methodologies, Technical documentation, Data structuring for risk tools
Preferred skills
TurboAC, Risk management platforms
Technologies
TurboAC, Excel
Responsibilities
Conduct technical review of the PHA; Support development and technical review of BE CT CHA and platform CHA; Ensure alignment of risks and RCMs with applicable standards; Contribute to development of the Platform Risk Management Plan (RMP); Participate in Functional Failure Analysis including identification of system-level effects and defect classification; Review and structure existing FMEAs for integration into risk management tools.
Seniority
Senior, hands-on IC