Sanofi-Aventis Deutschland GmbH
Single-Use Systems Expert(m/w/x)
Full-timeOn-siteExperienced
Frankfurt am Main
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FRFresenius Medical Care D. GmbH
(Senior) Expert Biocompatibility(m/w/x)
Bad Homburg vor der Höhe
Full-timeOn-siteExperienced
Nejo AI Summary
Evaluating biocompatibility of medical devices, including safety and risk assessments. Deep knowledge of biocompatibility testing and evaluations required. Career planning opportunities, professional development.
Requirements
- Master’s degree in scientific, engineering, or technical field
- Highly experienced in writing biocompatibility evaluations
- Deep knowledge of biocompatibility testing and evaluations
- Application of Design Control and Risk Management
- Familiarity with FDA CFR 820, ISO 13485, and ISO 14971
- Strong knowledge of medical device risk management process and regulations
- Experience with product/design/development or quality engineering
- Experience with sterile disposables utilizing plastic processes
- Ability to communicate technical information to non-technical audiences
- Familiarity with agile methodology
- Proven track record in project and/or test management
- Proficient with ALM and PDM systems
- Familiarity with medical device durables and disposables
- Willingness to travel monthly and work in different time zones
Tasks
- Evaluate biocompatibility of medical devices
- Perform safety and risk assessments
- Plan, interpret, and evaluate analytical and biological tests
- Compile overall biological safety assessments
- Derive biocompatibility strategy details
- Characterize materials and sample product groups
- Act as sponsor and study monitor for biocompatibility studies
- Support biocompatibility projects and coordinate strategies
- Align sampling and testing strategies
- Support product responsibles in applying strategies
- Coordinate global laboratory partners and methods
- Ensure timely implementation of regulatory changes
- Contribute to supplier agreements and material selection
- Maintain biocompatibility files for assigned product groups
Work Experience
- 2 - 8 years
Education
- Master's degree
Languages
- German – Fluent
- English – Fluent
Tools & Technologies
- ISO 10993
- Design Control
- Risk Management
- FDA CFR 820
- ISO 13485
- ISO 14971
- agile methodology
- ALM
- PDM
- injection molding
- extruding
Benefits
Career Advancement
- Career planning opportunities
Learning & Development
- Professional development
Informal Culture
- Innovative corporate culture
- Collegial company culture
Corporate Discounts
- Global corporation benefits
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Medical Care D. 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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FRFresenius Medical Care D. GmbH
(Senior) Expert Biocompatibility(m/w/x)
Bad Homburg vor der Höhe
Full-timeOn-siteExperienced
Nejo AI Summary
Evaluating biocompatibility of medical devices, including safety and risk assessments. Deep knowledge of biocompatibility testing and evaluations required. Career planning opportunities, professional development.
Requirements
- Master’s degree in scientific, engineering, or technical field
- Highly experienced in writing biocompatibility evaluations
- Deep knowledge of biocompatibility testing and evaluations
- Application of Design Control and Risk Management
- Familiarity with FDA CFR 820, ISO 13485, and ISO 14971
- Strong knowledge of medical device risk management process and regulations
- Experience with product/design/development or quality engineering
- Experience with sterile disposables utilizing plastic processes
- Ability to communicate technical information to non-technical audiences
- Familiarity with agile methodology
- Proven track record in project and/or test management
- Proficient with ALM and PDM systems
- Familiarity with medical device durables and disposables
- Willingness to travel monthly and work in different time zones
Tasks
- Evaluate biocompatibility of medical devices
- Perform safety and risk assessments
- Plan, interpret, and evaluate analytical and biological tests
- Compile overall biological safety assessments
- Derive biocompatibility strategy details
- Characterize materials and sample product groups
- Act as sponsor and study monitor for biocompatibility studies
- Support biocompatibility projects and coordinate strategies
- Align sampling and testing strategies
- Support product responsibles in applying strategies
- Coordinate global laboratory partners and methods
- Ensure timely implementation of regulatory changes
- Contribute to supplier agreements and material selection
- Maintain biocompatibility files for assigned product groups
Work Experience
- 2 - 8 years
Education
- Master's degree
Languages
- German – Fluent
- English – Fluent
Tools & Technologies
- ISO 10993
- Design Control
- Risk Management
- FDA CFR 820
- ISO 13485
- ISO 14971
- agile methodology
- ALM
- PDM
- injection molding
- extruding
Benefits
Career Advancement
- Career planning opportunities
Learning & Development
- Professional development
Informal Culture
- Innovative corporate culture
- Collegial company culture
Corporate Discounts
- Global corporation benefits
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Medical Care D. 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Fresenius Medical Care D. GmbH
Industry
Healthcare
Description
The company is dedicated to improving the lives of patients with chronic kidney disease through innovative, high-quality products and treatments.
Not a perfect match?
- Sanofi-Aventis Deutschland GmbH
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Process Architect Quality Management(m/w/x)
Full-timeOn-siteExperiencedBad Homburg vor der Höhe - Sanofi-Aventis Deutschland GmbH
Key Expert Downstream Processing(m/w/x)
Full-timeOn-siteExperiencedFrankfurt am Mainfrom 83,784 - 125,784 / year - Fresenius Kabi Deutschland GmbH
Manufacturing Sciences & Technology Business Partner(m/w/x)
Full-timeOn-siteSeniorBad Homburg vor der Höhe