Philips
Safety Risk Manager(m/w/x)
Full-timeOn-siteExperienced
Böblingen
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Guiding expert team on safety for active medical devices, ensuring ISO/IEC standards adherence. 1+ years in safety for active medical devices, with EU MDR and FDA 21CFR 820 knowledge essential. 30 days annual leave, subsidized Germany ticket, private leasing options.
Requirements
- 2+ years of experience in medical product development
- 1+ years of experience in safety risk management for active medical devices
- Fundamental knowledge of regulations related to risk management
- Knowledge of ISO14971, FDA Regulations 21CFR 820, EU MDR, IEC 60601-1, IEC 62304, IEC 62366-1
- Solid methodology know-how: FMEA, FTA, PHA
- Understanding of Safety Risk Engineering in system engineering workflow
- Strong communication and moderation skills
- University Degree Bachelor / Master in EE/ME/SW/Systems Engineering/Medical
- Fluency in both English and German
Tasks
- Guide safety risk management activities of a cross-functional expert team
- Ensure adherence to ISO14971, IEC62366-1, IEC60601-1, and IEC 62304 standards
- Manage risk management documents in the technical file
- Contribute to post-release risk management activities
- Create and maintain risk management plans
- Create and maintain risk management matrices
- Ensure completeness and quality of risk controls
- Ensure traceability between risk management artifacts, requirements, and verification
Work Experience
- 2 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Benefits
More Vacation Days
- 30 days annual leave
Public Transport Subsidies
- Subsidized Germany ticket
Company Vehicle
- Leasing opportunities for private use
Learning & Development
- Wide range of professional training courses
Mentorship & Coaching
- Personal development support
Retirement Plans
- Employer-funded pension plan
Generous Parental Leave
- Two paid weeks off after partner's birth
Corporate Discounts
- Discount on Philips products
Snacks & Drinks
- Free drinks in canteen
- Low prices in Café Philistro
Informal Culture
- Informal culture
Purpose-Driven Work
- Paid day for voluntary work
Team Events
- Various team 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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Guiding expert team on safety for active medical devices, ensuring ISO/IEC standards adherence. 1+ years in safety for active medical devices, with EU MDR and FDA 21CFR 820 knowledge essential. 30 days annual leave, subsidized Germany ticket, private leasing options.
Requirements
- 2+ years of experience in medical product development
- 1+ years of experience in safety risk management for active medical devices
- Fundamental knowledge of regulations related to risk management
- Knowledge of ISO14971, FDA Regulations 21CFR 820, EU MDR, IEC 60601-1, IEC 62304, IEC 62366-1
- Solid methodology know-how: FMEA, FTA, PHA
- Understanding of Safety Risk Engineering in system engineering workflow
- Strong communication and moderation skills
- University Degree Bachelor / Master in EE/ME/SW/Systems Engineering/Medical
- Fluency in both English and German
Tasks
- Guide safety risk management activities of a cross-functional expert team
- Ensure adherence to ISO14971, IEC62366-1, IEC60601-1, and IEC 62304 standards
- Manage risk management documents in the technical file
- Contribute to post-release risk management activities
- Create and maintain risk management plans
- Create and maintain risk management matrices
- Ensure completeness and quality of risk controls
- Ensure traceability between risk management artifacts, requirements, and verification
Work Experience
- 2 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Benefits
More Vacation Days
- 30 days annual leave
Public Transport Subsidies
- Subsidized Germany ticket
Company Vehicle
- Leasing opportunities for private use
Learning & Development
- Wide range of professional training courses
Mentorship & Coaching
- Personal development support
Retirement Plans
- Employer-funded pension plan
Generous Parental Leave
- Two paid weeks off after partner's birth
Corporate Discounts
- Discount on Philips products
Snacks & Drinks
- Free drinks in canteen
- Low prices in Café Philistro
Informal Culture
- Informal culture
Purpose-Driven Work
- Paid day for voluntary work
Team Events
- Various team 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.
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