Risk Manager Engineer (Madrid)

This role can be based in any of these EU countries: Spain, Poland, Bulgaria, France, Italy, Germany.

Responsibilities

• Lead and coordinate all risk management activities according to ISO 14971, ISO 13485, MDR and annex XVI.
• Plan, prepare and perform risk management for medical devices and aesthetic products according to project phases following all relevant internal procedures, processes, and external requirements for development products.
• Represent Risk Management on assigned development projects.
• Establish risk acceptance criteria for individual residual risks and the overall residual risk for specific devices in development and for legacy devices.
• Maintain a close link to the Human Factors/ Usability Engineering process to meet the needs and ensure the safety of all users and patients.
• Support creation of device design specifications to ensure that risk control measures are appropriate.
• Monitor that ris...