Safety Risk Engineer (m/f/d)
Core
Lead safety risk management for Philips Hospital Patient Monitoring platforms and products, ensuring adherence to medical device regulations and standards.
Role type
Senior Safety Risk Engineer (Medical Devices)
Builds
Safe hardware and software products for hospital patient monitoring
Domain
Healthcare technology / Medical device engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO14971, IEC62366-1, IEC60601-1, IEC 62304, FMEA, FTA, PHA, risk management plans, risk management matrices, traceability between risk artifacts and requirements
Preferred skills
Experience with software-intensive embedded systems, FDA Regulations 21CFR 820, EU MDR
Technologies
ISO14971, IEC62366-1, IEC60601-1, IEC 62304
Responsibilities
Guide and facilitate safety risk management activities for cross-functional teams, ensure adherence to process and applicable standards, own risk management documents in the technical file, contribute to post-release risk management, create and maintain risk management plans and matrices, ensure completeness and quality of risk controls, ensure traceability between risk management artifacts, requirements and verification
Seniority
Senior, hands-on IC