Fresenius Medical Care D. GmbH
(Junior) Expert Biocompatibility(m/w/x)
Full-timeOn-siteJunior
Sankt Wendel
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FRFresenius Medical Care D. GmbH
(Senior) Expert Biocompatibility(m/w/x)
Sankt Wendel
Full-timeOn-siteExperienced
Nejo AI Summary
Evaluating medical devices and raw materials for patient safety in chronic kidney disease treatment. Deep knowledge of ISO 10993 for medical device testing and evaluations required. Direct impact on patient lives with chronic kidney disease.
Requirements
- Master’s degree in scientific, engineering, or similar technical field
- Related working experience: 2–8 years
- Highly experienced in writing biocompatibility evaluations
- Deep 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
- Strong knowledge of medical device risk management process and related regulations
- Experience with product or design and development or quality engineering of sterile disposables utilizing various plastic processes
- Ability to communicate technical information to non-technical audiences
- Familiar with agile methodology
- Proven track record in project and/or test management
- Proficient with ALM and PDM systems
- Familiar with durables and disposables of medical devices
- Fluent 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 according to MDR and ISO 10993
- Perform safety and risk assessments based on raw materials and biocompatibility studies
- Plan and interpret analytical and biological tests from internal or external labs
- Compile biological safety assessments per ISO 10993-1
- Develop biocompatibility strategies for new products and material changes
- Act as sponsor and monitor for chemical and biocompatibility studies
- Coordinate support for biocompatibility projects and overarching strategies
- Align sampling and testing strategies with product teams
- Coordinate global laboratory partnerships and applied methods
- Manage biocompatibility files for assigned product groups
- Contribute to supplier agreements and specifications for biocompatibility
- Monitor regulatory changes and ensure timely implementation of methodologies
Work Experience
- 2 - 8 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- FDA CFR 820
- ISO 13485
- ISO 14971
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.
Not a perfect match?
- Fresenius Medical Care D. GmbH
Projektmanager - Qualitätssysteme(m/w/x)
Full-timeOn-siteExperiencedSankt Wendel - Fresenius Medical Care D. GmbH
Produktionsleiter:in Betrieb Sterile Lösungen(m/w/x)
Full-timeOn-siteExperiencedSankt Wendel - Fresenius Medical Care D. GmbH
Leiter Prozesskontrolle(m/w/x)
Full-timeOn-siteManagementSankt Wendel - Fresenius Medical Care
Laborant - Ansatz Sterile Lösungen(m/w/x)
Full-timeOn-siteSeniorSankt Wendel
FRFresenius Medical Care D. GmbH
(Senior) Expert Biocompatibility(m/w/x)
Sankt Wendel
Full-timeOn-siteExperienced
Nejo AI Summary
Evaluating medical devices and raw materials for patient safety in chronic kidney disease treatment. Deep knowledge of ISO 10993 for medical device testing and evaluations required. Direct impact on patient lives with chronic kidney disease.
Requirements
- Master’s degree in scientific, engineering, or similar technical field
- Related working experience: 2–8 years
- Highly experienced in writing biocompatibility evaluations
- Deep 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
- Strong knowledge of medical device risk management process and related regulations
- Experience with product or design and development or quality engineering of sterile disposables utilizing various plastic processes
- Ability to communicate technical information to non-technical audiences
- Familiar with agile methodology
- Proven track record in project and/or test management
- Proficient with ALM and PDM systems
- Familiar with durables and disposables of medical devices
- Fluent 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 according to MDR and ISO 10993
- Perform safety and risk assessments based on raw materials and biocompatibility studies
- Plan and interpret analytical and biological tests from internal or external labs
- Compile biological safety assessments per ISO 10993-1
- Develop biocompatibility strategies for new products and material changes
- Act as sponsor and monitor for chemical and biocompatibility studies
- Coordinate support for biocompatibility projects and overarching strategies
- Align sampling and testing strategies with product teams
- Coordinate global laboratory partnerships and applied methods
- Manage biocompatibility files for assigned product groups
- Contribute to supplier agreements and specifications for biocompatibility
- Monitor regulatory changes and ensure timely implementation of methodologies
Work Experience
- 2 - 8 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- FDA CFR 820
- ISO 13485
- ISO 14971
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
(Junior) Expert Biocompatibility(m/w/x)
Full-timeOn-siteJuniorSankt Wendel - Fresenius Medical Care D. GmbH
Projektmanager - Qualitätssysteme(m/w/x)
Full-timeOn-siteExperiencedSankt Wendel - Fresenius Medical Care D. GmbH
Produktionsleiter:in Betrieb Sterile Lösungen(m/w/x)
Full-timeOn-siteExperiencedSankt Wendel - Fresenius Medical Care D. GmbH
Leiter Prozesskontrolle(m/w/x)
Full-timeOn-siteManagementSankt Wendel - Fresenius Medical Care
Laborant - Ansatz Sterile Lösungen(m/w/x)
Full-timeOn-siteSeniorSankt Wendel