Device Quality Engineer - Device Risk Management and Surveillance Excellence
Core
Lead global processes for patient safety and regulatory compliance, specifically managing Device Risk Management, Clinical Evaluation, and Post-Market Surveillance for medical devices and drug-device combinations.
Role type
Senior process owner for device quality and risk management
Builds
Global risk management files, post-market surveillance deliverables, and harmonized risk management approaches
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 14971 Risk Management, Post-Market Surveillance (PMS), FMEA / Risk Analysis Tools, Regulatory Compliance (MDR / 21 CFR 820), Design Controls & DHF Management
Preferred skills
Complaint management, French or German language proficiency
Technologies
ISO 14971, MDR (2017/745), 21 CFR 820, FMEA, PHA
Responsibilities
Lead Device Risk Management, Clinical Evaluation, and Post-Market Surveillance processes as global process owner; Ensure SOPs align with regulations and drive continuous improvement; Analyze post-market data to identify trends and implement corrective actions; Develop new tools, training programs, and mentor colleagues on risk management methodologies; Facilitate dFMEA moderation sessions and ensure project teams utilize appropriate risk analysis tools; Author and maintain post-market surveillance deliverables; Support Design Controls implementation and Design History File maintenance.
Seniority
Senior, hands-on IC with process ownership