Senior Risk Management Engineer
Core
Lead risk management for medical devices and drug-device combination products, ensuring safety and regulatory compliance throughout the product lifecycle.
Role type
Senior Risk Management Engineer (Medical Devices)
Builds
Safe and effective medical devices and combination products for patients
Domain
Life Sciences / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 14971 risk methodologies, Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), root cause investigation, cross-functional stakeholder leadership, regulatory audit preparation, risk framework design
Preferred skills
GMP expectations knowledge, formal risk/quality certifications (IRCA, CQE), regulatory inspection experience, data analysis tools proficiency, team coaching, structured problem-solving
Technologies
Risk management software, digital data analysis tools
Responsibilities
Own Risk Management Files (RMF) and lead risk assessments for device programs; Design and maintain risk frameworks and documentation; Run failure mode analysis and hazard assessments with cross-functional teams; Coach teams in risk thinking and best practices; Support regulatory and audit readiness with risk rationales
Seniority
Senior, hands-on IC
