Safety Engineer
Core
Ensure medical devices are safe, effective, and secure throughout their entire lifecycle by championing product safety during development and maintaining risk management files.
Role type
Product Safety Engineer (Medical Devices)
Builds
Precision radiation medicine solutions for cancer care
Domain
Medical Devices / Radiation Therapy
Required skills
Risk management, Medical device regulations, ISO 13485, ISO 14971, IEC 60601, IEC 61508, IEC 62304, FDA, NMPA, MDR
Preferred skills
Engineering degree, Life Sciences background
Technologies
ISO 13485, ISO 14971, IEC 60601, IEC 61508, IEC 62304
Responsibilities
Lead product risk management activities, Identify and assess potential risks, Review and document risk management activities, Ensure compliance with regulatory requirements, Collaborate with cross-functional teams to embed safety awareness, Prepare and maintain risk management reports
Seniority
Mid-level, hands-on IC