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Risk Manager Medical Devices(m/w/x)
Description
You will drive the development of innovative medical products by managing complex risk files and leading FMEA teams to ensure safety and compliance throughout the entire product life cycle.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
Education
Work Experience
3 years
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
Tools & Technologies
Languages
English – Business Fluent
German – Business Fluent
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
- B. Braun Miethke GmbH & Co. KGFull-timeWith HomeofficeExperiencedPotsdam
- B. Braun Miethke GmbH & Co. KG
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Risk Manager Medical Devices(m/w/x)
The AI Job Search Engine
Description
You will drive the development of innovative medical products by managing complex risk files and leading FMEA teams to ensure safety and compliance throughout the entire product life cycle.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
Education
Work Experience
3 years
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
Tools & Technologies
Languages
English – Business Fluent
German – Business Fluent
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.
- B. Braun Miethke GmbH & Co. KG
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