Expert Biocompatibility

At Ypsomed, we develop innovative medical technology solutions that enable people with chronic conditions around the world to live independently. Our employees work in interdisciplinary teams, take responsibility, and shape the future of healthcare using cutting-edge technology. We foster an open and inclusive company culture that values diversity, welcomes new perspectives, and places meaningful work at the center of everything we do.

As Expert Biocompatibility, you will take responsibility for the biological evaluation of our products - from defining test strategies and coordinating external testing to preparing biological evaluation reports. Working closely with cross-functional teams, you will ensure global regulatory compliance and the highest standards of biological safety, actively contributing to product quality and patient safety.

Expert Biocompatibility | 80 - 100%

Ref. No. 7925

Location: Burgdorf | Hybrid

Support us in the production and development of cutting-edge medical technology solutions that enable people around the world to self-manage diabetes and other chronic diseases.

Your main tasks

• Define test strategies for the biological evaluation for individual products as well as product families
• Coordinate the biocompatibility testing outsourced to the external laboratories or support the Ypsomed teams in these activities
• Summarize test results of the chemical characterization studies (leachables, extractables and their toxicological assessment) and biological tests
• Create biological evaluation reports according to ISO 10993 series for Europe, USA and other countries
• Ensure global compliance with legal requirements and compliance with standards and guidelines on the biological safety of products
• Perform biocompatibility assessment of changes on approved products
• Support internal stakeholders with questions regarding biocompatibility and questions from regulatory authorities
• Maintain and develop current knowledge and expertise in existing regulations, global requirements and standards related to biological safety of medical devices

Your profile

• Master's degree in Medicine, Biology, Chemistry, Biochemistry, Toxicology, Biomedical Engineering or any related discipline
• At least 2 years work experience in the medical device and/or medical combination products field, biocompatibility and toxicology and experience with the above mentioned main tasks
• Collaborative team player who contributes positively to cross-functional teams
• Fluent in English and German, both written and verbal (B2)

Ypsomed - making the treatment of chronic diseases possible

More than 2,000 employees worldwide develop and produce injection and infusion systems for self-medication with the Ypsomed Group. We are a successful, rapidly growing, family-owned company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world. With our market-leading products and solutions, we enable people all over the globe to self-treatment. Despite chronic diseases such as diabetes, obesity, or certain types of cancer, they are provided with the greatest possible quality of life.

Contact

Annina Kistler
Human Resources Expert Recruiting

+41 (0) 34 424 24 07

Your future place of work

Burgdorf