Description

You will lead cross-functional teams to ensure the safety of hospital monitoring products, managing technical risk documentation and maintaining strict adherence to international medical standards.

Requirements

• •3+ years medical product development experience
• •1+ years safety risk management experience
• •Knowledge of ISO14971 and FDA regulations
• •Knowledge of EU MDR and IEC standards
• •Methodology know-how in FMEA, FTA, PHA
• •Understanding of Safety Risk Engineering
• •Strong communication and moderation skills
• •University degree in relevant engineering field
• •Fluency in English and German
• •Interest in the role

Tasks

• •Guide cross-functional safety risk management activities
• •Ensure adherence to ISO14971 and IEC standards
• •Manage risk management documents in technical files
• •Contribute to post-release risk management activities
• •Create and maintain risk management plans
• •Develop and update risk management matrices
• •Ensure completeness and quality of risk controls
• •Maintain traceability between artifacts, requirements, and verification

Tools & Technologies

Benefits