Safety Risk Engineer – Medical Devices

About the role

In this role you will become a member of our safety risk management team. As part of this team, you are responsible for the safety risk management of platforms and products of the Philips Hospital Patient Monitoring business.

Key responsibilities

• Guide and facilitate safety risk management activities of a cross‑functional expert team.
• Ensure adherence to processes and standards such as ISO 14971, IEC 62366‑1, IEC 60601‑1 and IEC 62304.
• Own the risk‑management documents in the technical file and contribute to post‑release activities.
• Create and maintain risk‑management plans and matrices, ensuring completeness, quality and traceability of risk controls.

Required profile

• 5+ years of medical product development experience with at least 3 years in safety risk management for active medical devices, preferably software‑intense embedded systems.
• Strong knowledge of regulations and standards including ISO 14971, FDA 21 CFR 820, EU MDR, IEC 60601‑1, IEC 62304 and IEC 62366‑1.
• Proficiency with risk analysis methods such as FMEA, FTA and PHA.
• Understanding of safety risk engineering within a systems‑engineering workflow.
• University degree (BSc/MSc) in EE, ME, Software, Systems Engineering or related field and advanced English.

Required skills

• ISO 14971
• IEC 62366‑1
• IEC 60601‑1
• IEC 62304
• FDA 21 CFR 820
• EU MDR
• FMEA
• FTA
• PHA