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Risk Manager Medical Devices(m/w/x)
Risk management for innovative drug delivery products, coordinating FMEA teams at a medical device manufacturer. Engineering degree and regulated medical device experience essential. Active product shaping role, flexible working time.
Requirements
- Master or Bachelor in Engineering
- Experience in ISO14971 or FMEA documentation
- Experience in regulated medical device industries
- AAMI TIR38-2019 documentation experience (plus)
- Desire for creative team collaboration
- Independent and structured working style
- Attention to detail and documentation skills
- Excellent communication skills
- Good English and German skills
Tasks
- Maintain and develop risk management files per ISO 14971
- Perform continuous risk assessments throughout the product life cycle
- Coordinate the design FMEA team and document results
- Lead the production process FMEA team and record findings
- Develop Safety Case documentation following US Standard AAMI TIR38-2019
Work Experience
- 3 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- ISO14971
- FMEA
- AAMI TIR38-2019
Benefits
Flexible Working
- Flexible working time
Purpose-Driven Work
- Active product shaping role
Informal Culture
- Friendly and international team
Job Security
- Prospective permanent position
Learning & Development
- Job related training events
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Risk Manager Medical Devices(m/w/x)
Risk management for innovative drug delivery products, coordinating FMEA teams at a medical device manufacturer. Engineering degree and regulated medical device experience essential. Active product shaping role, flexible working time.
Requirements
- Master or Bachelor in Engineering
- Experience in ISO14971 or FMEA documentation
- Experience in regulated medical device industries
- AAMI TIR38-2019 documentation experience (plus)
- Desire for creative team collaboration
- Independent and structured working style
- Attention to detail and documentation skills
- Excellent communication skills
- Good English and German skills
Tasks
- Maintain and develop risk management files per ISO 14971
- Perform continuous risk assessments throughout the product life cycle
- Coordinate the design FMEA team and document results
- Lead the production process FMEA team and record findings
- Develop Safety Case documentation following US Standard AAMI TIR38-2019
Work Experience
- 3 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- ISO14971
- FMEA
- AAMI TIR38-2019
Benefits
Flexible Working
- Flexible working time
Purpose-Driven Work
- Active product shaping role
Informal Culture
- Friendly and international team
Job Security
- Prospective permanent position
Learning & Development
- Job related training events
About the Company
B. Braun Miethke GmbH & Co. KG
Industry
Healthcare
Description
B. Braun Miethke develops innovative drug delivery products to meet unmet user and patient needs.
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