Job Description
Senior Risk Management Engineer, Medical Devices (ISO 14971/ IEC 60601/IEC 62304)
Vision RT is a rapidly growing MedTech transforming radiation therapy for cancer patients. With around 300 employees globally, we are the inventors and market leaders in Surface Guided Radiation Therapy (SGRT), used in 24 of the 25 “Best Hospitals for Cancer.” We operate under the Danish company William Demant Invest A/S.
About the role: You will sit with the compliance team, creating and maintaining Risk Management files for Vision RT medical devices, including pre‑ and post‑market risk analysis in an agile landscape.
Key Responsibilities:
- Lead the creation, maintenance, and continuous improvement of comprehensive Risk Management Files in accordance with ISO 14971;
- Develop Risk Traceability Matrices and conduct Change Control and Anomaly Risk Reviews;
- Drive risk assessments for design changes, ensuring appropriate risk cont...