Your role: 

• Guide and facilitate safety risk management activities of a cross-functional expert team

• Ensure adherence to process and applicable standards like ISO14971, IEC62366-1, IEC60601-1, and IEC 62304

• Ownership of the risk management documents in the technical file

• Contribute to post-release risk management activities

• Take operational responsibility for safety risk management in projects by

  • Creation and maintenance of risk management plans

  • Creation and maintenance of risk management matrices

  • Ensuring completeness and quality of risk controls

  • Ensuring traceability between risk management artifacts, requirements and verification

You should bring the following: 

• 5+ years proven experience in medical product development with 3+ years of experience in safety risk management for active medical devices preferably for software intense embedded systems.

• Fundamental knowledge of regulations related to risk management and the development of safe hardware and software products including ISO14971, FDA Regulations 21CFR 820, EU MDR, IEC 60601-1, IEC 62304, and IEC 62366-1.

• Solid methodology know-how: e.g. FMEA, FTA, PHA.

• Understanding of Safety Risk Engineering as integrated discipline in a system engineering workflow.

• Strong communication and moderation skills to lead discussions of cross-disciplinary teams.

• University Degree Bachelor / Master (EE/ME/SW/Systems Engineering/Medical)

• Advanced English

How We Work Together 

We believe that we achieve better results when we work together rather than apart. For this role this means to be on-site at least 3 days a week. 

About Philips 

We are a health technology company. We built our entire company around the belief that every human matters, and we wont stop until everybody everywhere has access to the quality healthcare that we all deserve. With patient safety and Quality as our fundamental premise, we focus on regulatory requirements and quality standards in our daily work. Do the work of your life to help the lives of others. 

• Learn more about our business. 

• Discover our rich and exciting history. 

• Learn more about our purpose. 

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here. 

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