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Safety Risk Engineer(m/w/x)
At health tech firm with global impact, guiding safety risk management for medical product development, ensuring ISO14971/IEC adherence. 3+ years medical product development experience and FMEA/FTA/PHA methodology know-how required. 30 days annual leave, subsidized Germany ticket, car/bike/smartphone leasing.
Requirements
- 3+ years experience in medical product development
- 1+ years experience in safety risk management
- Knowledge of risk management and development regulations
- Solid methodology know-how in FMEA, FTA, PHA
- Understanding of Safety Risk Engineering
- Strong communication and moderation skills
- University Degree in Engineering or Medical field
- Fluency in English and German
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
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
Company Bike
- Bicycle leasing
Company Vehicle
- Car leasing
Modern Equipment
- Smartphone leasing
Learning & Development
- Professional training courses
- Personal development courses
Healthcare & Fitness
- Healthcare
Retirement Plans
- Employer-funded pension plan
Generous Parental Leave
- Two-week paid partner leave
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 voluntary work day
Team Events
- Team and cultural activities
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Safety Risk Engineer(m/w/x)
At health tech firm with global impact, guiding safety risk management for medical product development, ensuring ISO14971/IEC adherence. 3+ years medical product development experience and FMEA/FTA/PHA methodology know-how required. 30 days annual leave, subsidized Germany ticket, car/bike/smartphone leasing.
Requirements
- 3+ years experience in medical product development
- 1+ years experience in safety risk management
- Knowledge of risk management and development regulations
- Solid methodology know-how in FMEA, FTA, PHA
- Understanding of Safety Risk Engineering
- Strong communication and moderation skills
- University Degree in Engineering or Medical field
- Fluency in English and German
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
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
Company Bike
- Bicycle leasing
Company Vehicle
- Car leasing
Modern Equipment
- Smartphone leasing
Learning & Development
- Professional training courses
- Personal development courses
Healthcare & Fitness
- Healthcare
Retirement Plans
- Employer-funded pension plan
Generous Parental Leave
- Two-week paid partner leave
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 voluntary work day
Team Events
- Team and cultural activities
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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