Safety Risk Engineer; m​/f​/d

Safety Risk Engineer (m/f/d)

In this role you will become a member of our safety risk management team. As part of this team, you are responsible for the safety risk management of platforms and products of the Philips Hospital Patient Monitoring business.

Your role:

• Guide and facilitate safety risk management activities of a cross-functional expert team
• Ensure adherence to process and applicable standards like ISO
  14971, IEC
  62366-1, IEC
  60601-1, 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:

• 3+ years proven experience in medical product development with 1+ 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 ISO
  14971, FDA Regulations 21
  
  CFR 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)
• Fluent in both English and German

Philips benefits for you:

• Annual leave: 30 days
• Mobility and devices: subsidized Germany ticket (instead of 58€ only 35,10€), leasing opportunities for private use (bicycles, cars, smartphones,…)
• Philips University & Philips in Balance:
  Wide range of professional training courses and for personal development & Healthcare
• Philips Pension Fund:
  Employer-funded pension plan
• “Partnerzeit” – two paid weeks off after your partner has given birth
• Philips My Shop :
  Discount on Philips products
• Meals:
  Free drinks and low prices in our canteen and CaféPhilistro
• Culture:
  Informal culture, a paid day for voluntary work, various team/cultural activities (on sustainability, diversity, ...), etc.

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.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't 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.

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 rn more about our commitment to diversity and inclusion here.

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