W.O.M. World of Medicine GmbH
Mechnical Design Engineer(m/w/x)
Full-timeOn-siteExperienced
Berlin
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W.W.O.M. World of Medicine GmbH
Design Assurance Engineer Medical Devices(m/w/x)
Berlin
Full-timeOn-siteExperienced
Nejo AI Summary
Design Control document review for engineered components in healthcare, ensuring MDR/CFR820 compliance and risk management. 2+ years professional experience with product quality in a highly regulated industry required. Direct involvement in product lifecycle from design to market.
Requirements
- Completed technical and/or physical studies
- At least 2 years of professional experience
- Experience with product quality in a highly regulated industry
- Experience in theory and application of quality methods and techniques
- English fluency
- German language skills would be a plus
- Quality-consciousness
- Trustworthiness
- Reliability
- Team player
- Good communication skills
- Structured and systematic way of working
Tasks
- Create an overall quality plan
- Review design verification and validation specifications
- Review test specifications and reports for medical devices
- Review Design Control documents according to GDP and MDR 2017/CFR820
- Lead and contribute to risk management activities
- Participate in FMEA and other quality assurance tasks
- Support the creation of a document plan and overall VnV plan
- Contribute to risk management content throughout product development
- Review the completeness of risk analysis
- Evaluate risk-reducing measures for severity and probability
- Create and review evidence for implementation of measures
- Prepare test specifications and requirements for series testing
- Participate in process synchronization and improvement measures
- Conduct failure analysis for field returns and during development
- Ensure compliance with quality, safety, and environmental regulations
Work Experience
- 2 years
Education
- Vocational certification
Languages
- English – Business Fluent
- German – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of W.O.M. World of Medicine GmbH 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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W.W.O.M. World of Medicine GmbH
Design Assurance Engineer Medical Devices(m/w/x)
Berlin
Full-timeOn-siteExperienced
Nejo AI Summary
Design Control document review for engineered components in healthcare, ensuring MDR/CFR820 compliance and risk management. 2+ years professional experience with product quality in a highly regulated industry required. Direct involvement in product lifecycle from design to market.
Requirements
- Completed technical and/or physical studies
- At least 2 years of professional experience
- Experience with product quality in a highly regulated industry
- Experience in theory and application of quality methods and techniques
- English fluency
- German language skills would be a plus
- Quality-consciousness
- Trustworthiness
- Reliability
- Team player
- Good communication skills
- Structured and systematic way of working
Tasks
- Create an overall quality plan
- Review design verification and validation specifications
- Review test specifications and reports for medical devices
- Review Design Control documents according to GDP and MDR 2017/CFR820
- Lead and contribute to risk management activities
- Participate in FMEA and other quality assurance tasks
- Support the creation of a document plan and overall VnV plan
- Contribute to risk management content throughout product development
- Review the completeness of risk analysis
- Evaluate risk-reducing measures for severity and probability
- Create and review evidence for implementation of measures
- Prepare test specifications and requirements for series testing
- Participate in process synchronization and improvement measures
- Conduct failure analysis for field returns and during development
- Ensure compliance with quality, safety, and environmental regulations
Work Experience
- 2 years
Education
- Vocational certification
Languages
- English – Business Fluent
- German – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of W.O.M. World of Medicine GmbH 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
W.O.M. World of Medicine GmbH
Industry
Healthcare
Description
The company creates engineered components and sub-systems for healthcare and advanced manufacturing, enhancing productivity and precision.
Not a perfect match?
- W.O.M. World of Medicine GmbH
Mechnical Design Engineer(m/w/x)
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Mechanical Design Engineer(m/w/x)
Full-timeOn-siteExperiencedBerlin - W.O.M. World of Medicine GmbH
Systems Engineer Disposables(m/w/x)
Full-timeOn-siteExperiencedBerlin - W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist Medical Devices(m/w/x)
Full-timeOn-siteSeniorBerlin - Personalvermittlung Wanka
Qualitätsingenieur(m/w/x)
Full-timeOn-siteExperiencedBerlin