Philips
Safety Risk Manager(m/w/x)
Full-timeOn-siteExperienced
Böblingen
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Managing risk documents in technical files for health tech products, ensuring ISO14971 and IEC standards. 3+ years medical product development experience, FDA regulations and FMEA methodology knowledge required. 30 days annual leave, subsidized Germany ticket.
Requirements
- 3+ years medical product development experience
- 1+ years safety risk management experience
- Knowledge of ISO14971 and FDA regulations
- Knowledge of EU MDR and IEC standards
- Methodology know-how in FMEA, FTA, PHA
- Understanding of Safety Risk Engineering
- Strong communication and moderation skills
- University degree in relevant engineering field
- Fluency in English and German
- Interest in the role
Tasks
- Guide cross-functional safety risk management activities
- Ensure adherence to ISO14971 and IEC standards
- Manage risk management documents in technical files
- Contribute to post-release risk management activities
- Create and maintain risk management plans
- Develop and update risk management matrices
- Ensure completeness and quality of risk controls
- Maintain traceability between artifacts, requirements, and verification
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- ISO14971
- FDA Regulations 21CFR 820
- EU MDR
- IEC 60601-1
- IEC 62304
- IEC 62366-1
- FMEA
- FTA
- PHA
Benefits
More Vacation Days
- 30 days annual leave
Public Transport Subsidies
- Subsidized Germany ticket
Modern Equipment
- Device leasing opportunities
Learning & Development
- Professional training courses
Healthcare & Fitness
- Personal development and healthcare
Retirement Plans
- Employer-funded pension plan
Generous Parental Leave
- Two paid weeks partnerzeit
Corporate Discounts
- Discount on Philips products
Snacks & Drinks
- Free drinks
Free or Subsidized Food
- Subsidized canteen and café
Informal Culture
- Informal culture
Purpose-Driven Work
- Paid day for voluntary work
Team Events
- Team and cultural activities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Philips and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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Managing risk documents in technical files for health tech products, ensuring ISO14971 and IEC standards. 3+ years medical product development experience, FDA regulations and FMEA methodology knowledge required. 30 days annual leave, subsidized Germany ticket.
Requirements
- 3+ years medical product development experience
- 1+ years safety risk management experience
- Knowledge of ISO14971 and FDA regulations
- Knowledge of EU MDR and IEC standards
- Methodology know-how in FMEA, FTA, PHA
- Understanding of Safety Risk Engineering
- Strong communication and moderation skills
- University degree in relevant engineering field
- Fluency in English and German
- Interest in the role
Tasks
- Guide cross-functional safety risk management activities
- Ensure adherence to ISO14971 and IEC standards
- Manage risk management documents in technical files
- Contribute to post-release risk management activities
- Create and maintain risk management plans
- Develop and update risk management matrices
- Ensure completeness and quality of risk controls
- Maintain traceability between artifacts, requirements, and verification
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- ISO14971
- FDA Regulations 21CFR 820
- EU MDR
- IEC 60601-1
- IEC 62304
- IEC 62366-1
- FMEA
- FTA
- PHA
Benefits
More Vacation Days
- 30 days annual leave
Public Transport Subsidies
- Subsidized Germany ticket
Modern Equipment
- Device leasing opportunities
Learning & Development
- Professional training courses
Healthcare & Fitness
- Personal development and healthcare
Retirement Plans
- Employer-funded pension plan
Generous Parental Leave
- Two paid weeks partnerzeit
Corporate Discounts
- Discount on Philips products
Snacks & Drinks
- Free drinks
Free or Subsidized Food
- Subsidized canteen and café
Informal Culture
- Informal culture
Purpose-Driven Work
- Paid day for voluntary work
Team Events
- Team and cultural activities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Philips and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Philips
Industry
Healthcare
Description
Das Unternehmen trägt durch innovative Lösungen zur Verbesserung der Lebensqualität von 3 Milliarden Menschen bei.
Not a perfect match?
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