Beschreibung

As a Safety Risk Manager, you will play a crucial role in overseeing safety risk management for Philips Hospital Patient Monitoring products. Your daily tasks will involve guiding cross-functional teams, ensuring compliance with industry standards, and maintaining essential risk management documentation.

Anforderungen

• •2+ years of experience in medical product development
• •1+ years of experience in safety risk management for active medical devices
• •Fundamental knowledge of regulations related to risk management
• •Knowledge of ISO14971, FDA Regulations 21CFR 820, EU MDR, IEC 60601-1, IEC 62304, and IEC 62366-1
• •Solid methodology know-how: FMEA, FTA, PHA
• •Understanding of Safety Risk Engineering in system engineering workflow
• •Strong communication and moderation skills
• •University Degree Bachelor / Master in EE/ME/SW/Systems Engineering/Medical
• •Fluency in English and German

Aufgaben

• •Guide safety risk management activities of a cross-functional expert team
• •Ensure adherence to applicable standards like ISO14971, IEC62366-1, IEC60601-1, and IEC 62304
• •Manage risk management documents in the technical file
• •Contribute to post-release risk management activities
• •Create and maintain risk management plans
• •Create and maintain risk management matrices
• •Ensure completeness and quality of risk controls
• •Ensure traceability between risk management artifacts, requirements, and verification

Benefits