Safety Engineer
Core
Ensure medical devices are safe, effective, and secure throughout their lifecycle by leading risk management activities and driving process improvements.
Role type
Product Safety Engineer (Medical Devices)
Builds
Precision radiation medicine solutions and medical devices
Domain
Healthcare / Medical Devices / Radiation Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Product risk management, Medical device regulations (ISO 13485, ISO 14971, IEC 60601, IEC 61508, IEC 62304, FDA, NMPA, MDR), Regulatory compliance, Cross-functional collaboration, Post-market surveillance
Preferred skills
Engineering or Life Sciences degree, Experience in highly regulated environments
Technologies
ISO 13485, ISO 14971, IEC 60601, IEC 61508, IEC 62304, FDA, NMPA, MDR
Responsibilities
Lead product risk management activities throughout the development lifecycle, Identify and assess potential risks to reduce them to acceptable levels, Review and document risk management activities for release decisions, Ensure products meet regulatory and risk management requirements, Collaborate with cross-functional teams to embed safety awareness, Prepare and maintain risk management reports and post-market reviews
Seniority
Mid-level, hands-on IC
