Safety Risk Manager (m/w/d) - fixed-term

Philips; Deutschland; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A health technology company is seeking a Safety Risk Manager with experience in medical product development and safety risk management for active medical devices. The ideal candidate should have a strong understanding of regulations and methodologies involved in risk management. This position mandates strong communication skills and requires fluency in both English and German. A collaborative work environment with a focus on patient safety is a crucial aspect of this role.

Leistungen

30 days annual leave

Subsidized Germany ticket

Wide range of training courses

Employer-funded pension plan

Two paid weeks off for partner's birth

Discount on Philips products

Free drinks in canteen

Various team activities

Qualifikationen

• 2+ years of experience in medical product development, with 1+ years in safety risk management.
• Fundamental knowledge of ISO14971, FDA Regulations 21CFR 820, EU MDR, IEC 60601-1.
• Solid methodology know-how: FMEA, FTA, PHA.

Aufgaben

• Guide and facilitate safety risk management activities.
• Ensure adherence to applicable standards.
• Contribute to post-release risk management activities.

Kenntnisse

Medical product development experience

Safety risk management

Strong communication skills

Team moderation skills

Fluent in English and German

Ausbildung

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

Jobbeschreibung

Job Title

Safety Risk Manager (m/w/d) - fixed term

The position is limited until 15.12.2026

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

• 2+ 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 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)
• 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 MyShop: Discount on Philips products
• Meals: Free drinks and low prices in our canteen and Café Philistro
• 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.

About Philips

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.

Additional Information

• 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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