Safety Risk Engineer (m/f/d)

Reposted 12 Days Ago
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Böblingen, Baden-Württemberg, DEU
In-Office
Mid level
Healthtech • Telehealth
The Role
Responsible for safety risk management in medical product development, guiding teams, ensuring compliance with standards, and managing risk documentation.
Summary Generated by Built In
Job TitleSafety Risk Engineer (m/f/d)

Job Description

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 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: 

  • 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 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. 

  • 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

#LI-OFFICE

Skills Required

  • 3+ years experience in medical product development
  • 1+ years experience in safety risk management for active medical devices
  • Knowledge of regulations like ISO14971, FDA Regulations, EU MDR
  • Solid methodology know-how: FMEA, FTA, PHA
  • University Degree Bachelor / Master (EE/ME/SW/Systems Engineering/Medical)
  • Fluent in English and German

Philips Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Philips and has not been reviewed or approved by Philips.

  • Retirement Support Retirement support is positioned as a standout, including a strong 401(k) match (often described at 7%) alongside pensions in some contexts.
  • Flexible Benefits Flexible benefits are emphasized through choice in health insurance options and a broad “Total Rewards” approach that combines compensation, health and wellness, and work-life support.
  • Leave & Time Off Breadth Leave and time off breadth appears strong, with generous paid time off and policies covering parental leave, caregiving responsibilities, volunteering, and family medical leave.

Philips Insights

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The Company
Alpharetta, GA
80,000 Employees
Year Founded: 1891

What We Do

Do the work of your life to help the lives of others. As a leading health technology company, it is our purpose to improve people’s health and well-being through meaningful innovation. Our goal is to improve 2.5 billion lives per year by 2030. ​ ​ We also strive to be the best place to work for people who share our passion, by promoting personal development, inclusion and diversity while acting responsibly towards our planet and society.

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