Staff Risk Management Engineer
Core
Assures new medical devices perform functions safely and establishes compliance with quality systems by collaborating with clinical, design, and regulatory teams to mitigate and monitor risk.
Role type
Staff Risk Management Engineer (Medical Devices)
Builds
Risk management plans, hazard analyses, and compliance documentation for electrophysiology medical devices.
Domain
Healthcare / Medical Devices / Quality Engineering
Required skills
Risk management planning, System Hazard Analysis, FMEA, FTA, Traceability management, CAPA, Regulatory compliance (FDA/GMP/ISO 13485), Cross-functional collaboration
Preferred skills
Medical device software experience, Advanced degree, Reliability methodologies, Statistics, ISO 14971/IEC 60601/IEC 62304 standards knowledge
Technologies
FMEA, FTA, QMS tools
Responsibilities
Support system/product risk management planning and requirements development, Analyze and incorporate legacy inputs and cybersecurity risks, Maintain traceability among hazards and risk controls, Lead post-market signal tracking and risk file updates, Support CAPA efforts and process improvements, Backroom support for audits
Seniority
Staff, hands-on IC with strategic cross-functional leadership