Fresenius Medical Care D. GmbH
(Senior) Expert Biocompatibility(m/w/x)
Full-timeOn-siteExperienced
Sankt Wendel
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FRFresenius Medical Care D. GmbH
(Junior) Expert Biocompatibility(m/w/x)
Sankt Wendel
Full-timeOn-siteJunior
Nejo AI Summary
Evaluating biocompatibility of medical devices and raw materials for kidney disease treatment at a medical product developer. Knowledge of ISO 10993, FDA CFR 820, and ISO 13485 for medical devices required. Standard work week.
Requirements
- Bachelor’s or master’s degree in scientific, engineering, or similar technical field
- 1 to 5 years of related working experience
- First experience in writing biocompatibility evaluations
- Knowledge of biocompatibility testing and evaluations of medical devices according to ISO 10993
- Application of Design Control and Risk Management, knowledge of FDA CFR 820, ISO 13485, and ISO 14971
- Knowledge of medical device risk management process and related regulations
- Experience with product or design and development or quality engineering of sterile disposables
- Ability to communicate technical information to non-technical audiences
- Familiarity with agile methodology
- First experience with ALM and PDM systems
- Familiarity with durables and disposables of medical devices
- Fluency in German and English, both written and spoken
- Willingness to travel on an average monthly cadence and to work in different time zones
Tasks
- Evaluate biocompatibility of medical devices
- Support safety and risk assessments based on raw materials
- Interpret and evaluate analytical and biological tests
- Assist in compiling biological safety assessments
- Derive biocompatibility strategy details
- Act as sponsor and monitor for biocompatibility studies
- Coordinate biocompatibility project support
- Align sampling and testing strategies
- Coordinate global laboratory partner alignment
- Manage biocompatibility files for assigned product groups
- Contribute to supplier agreements for biocompatibility
- Monitor regulation changes and ensure timely implementation
Work Experience
- 1 - 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- ISO 10993
- FDA CFR 820
- ISO 13485
- ISO 14971
Benefits
Career Advancement
- Individual career planning
Learning & Development
- Professional development opportunities
Startup Environment
- Innovative thinking culture
Informal Culture
- Collegial culture
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
(Junior) Expert Biocompatibility(m/w/x)
Sankt Wendel
Full-timeOn-siteJunior
Nejo AI Summary
Evaluating biocompatibility of medical devices and raw materials for kidney disease treatment at a medical product developer. Knowledge of ISO 10993, FDA CFR 820, and ISO 13485 for medical devices required. Standard work week.
Requirements
- Bachelor’s or master’s degree in scientific, engineering, or similar technical field
- 1 to 5 years of related working experience
- First experience in writing biocompatibility evaluations
- Knowledge of biocompatibility testing and evaluations of medical devices according to ISO 10993
- Application of Design Control and Risk Management, knowledge of FDA CFR 820, ISO 13485, and ISO 14971
- Knowledge of medical device risk management process and related regulations
- Experience with product or design and development or quality engineering of sterile disposables
- Ability to communicate technical information to non-technical audiences
- Familiarity with agile methodology
- First experience with ALM and PDM systems
- Familiarity with durables and disposables of medical devices
- Fluency in German and English, both written and spoken
- Willingness to travel on an average monthly cadence and to work in different time zones
Tasks
- Evaluate biocompatibility of medical devices
- Support safety and risk assessments based on raw materials
- Interpret and evaluate analytical and biological tests
- Assist in compiling biological safety assessments
- Derive biocompatibility strategy details
- Act as sponsor and monitor for biocompatibility studies
- Coordinate biocompatibility project support
- Align sampling and testing strategies
- Coordinate global laboratory partner alignment
- Manage biocompatibility files for assigned product groups
- Contribute to supplier agreements for biocompatibility
- Monitor regulation changes and ensure timely implementation
Work Experience
- 1 - 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- ISO 10993
- FDA CFR 820
- ISO 13485
- ISO 14971
Benefits
Career Advancement
- Individual career planning
Learning & Development
- Professional development opportunities
Startup Environment
- Innovative thinking culture
Informal Culture
- Collegial culture
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.
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?
- Fresenius Medical Care D. GmbH
(Senior) Expert Biocompatibility(m/w/x)
Full-timeOn-siteExperiencedSankt Wendel - Fresenius Medical Care D. GmbH
Projektmanager - Qualitätssysteme(m/w/x)
Full-timeOn-siteExperiencedSankt Wendel - HYDAC
Mitarbeiter Tax Compliance(m/w/x)
Full-timeOn-siteJuniorNeunkirchen - Fresenius Medical Care D. GmbH
Pharmaziepraktikum(m/w/x)
Full-timeInternshipOn-siteSankt Wendel - Fresenius Medical Care
Apotheker im praktischen Jahr(m/w/x)
Full-timeInternshipOn-siteSankt Wendel