Material & Sterilization Expert - Insulin Delivery Systems

Ypsomed Diabetes Care AG is a new, independent medtech company and the leading developer and manufacturer of insulin pump systems for diabetes treatment. To strengthen the Product Safety department, we are looking for a new employee for our new location in the new building directly at Burgdorf railway station.
Material & Sterilization Expert - Insulin Delivery Systems | 80 - 100%
Ref. No. 7705
Location: Burgdorf, Solothurn | Hybrid
Contribute to the cutting-edge development of medical technology solutions and thrive in an environment that offers a great amount of autonomy.
Your main tasks
• Evaluate and select suitable materials (e.g., polymers, elastomers) for components used in insulin infusion systems
• Ensure compliance with global material regulations (EU MDR, REACH, RoHS, FDA 21 CFR, ISO 10993-18)
• Assess material compatibility with sterilization methods (EtO, gamma, steam, etc.), with a special focus on ethylene oxide (EtO)
• Collaborate with suppliers to obtain material disclosure, regulatory declarations, and support qualification of new materials
• Maintain accurate material documentation for technical files and regulatory submissions
• Maintain and manage the internal substances and materials database

Your profile
• MSc or PhD in Materials Science, Polymer Engineering, Biomedical Engineering, or a related discipline
• At least 3–5 years of experience in material evaluation and compliance within the medical device industry
• Knowledgeable in material regulations and documentation requirements for global submissions
• Proven experience with sterilization methods and their impact on materials
• Proficient in technical standards ISO 11607, ISO 11135 and familiar with ISO 10993, and FDA guidance documents
• Strong analytical and decision-making skills related to material science and compliance
• Excellent communication and documentation abilities
• Ability to collaborate cross-functionally and manage technical discussions with suppliers and testing partners
• Optional: Knowledge in biocompatibility, drug-material interaction, and finite element modeling (FEM)

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
Marcel Brader
Human Resources Expert Recruiting
+41 (0) 34 424 42 79
Your future place of work
Burgdorf
Solothurn