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B.B. Braun Miethke GmbH & Co. KG

Risk Manager Medical Devices(m/w/x)

Potsdam
Full-timeWith Home OfficeExperienced
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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.

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 FluentGerman – Business Fluent

Tools & Technologies

ISO14971FMEAAAMI 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
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of B. Braun Miethke GmbH & Co. KG 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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