Senior R&D Engineer (m/f/d)

devie medical GmbH is pioneering innovative heart valve prostheses to treat bacterial heart infections. These prostheses, implanted via a catheter system, are designed with drug-releasing layers that target infections directly in the heart, eliminating the need for open-heart surgery.

Our interdisciplinary team, comprising engineers, scientists, and medical doctors, is based in Jena, Thuringia. As a start-up with 8 dedicated employees, we are embedded in a robust network of research institutions and experts. We manage the entire development process, from designing the heart valve framework to producing drug-releasing polymer coatings, in collaboration with esteemed partners and contractors.

We are currently seeking a Senior R&D Engineer (m/f/d) to join our development team.

Responsibilities:

• Optimize existing NiTi stent design of aortic heart valve prostheses
• Construct NiTi valve frame models for laser cutting and furthermore parts for 3d printing using standard CAD software (Solid works, AutoCad)
• Perform hands-on mechanical testing, polymer processing, and pharmacological concepts
• Contribute to process development and production of drug-containing polymer materials through extrusion
• Document test results independently and prepare test reports
• Contribute to the development of a catheter-based delivery system for heart valve prosthesis
• Manage projects and maintain correspondence with contractors and external partners
• create, review and approve protocols and generate reports in accordance with ISO 13485

Qualifications:

• MSc or equivalent in Mechanical Engineering, Biomedical Engineering
• 3+ years of experience in medical device development
• Strong experience with NiTi shape memory alloy and stent design
• Confident handling of 3D-CAD systems (e.g. Solidworks)
• Experience in the interpretation of FEA data and durability testing
• Proficiency in hands-on skills
• Precise, structured, and detail-oriented work ethic
• Ability to work independently and responsibly
• Proficiency with MS Office applications
• knowledge of the regulatory requirements of EMA & FDA for the approval of medical implants, preferably of structural heart implants
• language proficiency in English, additional language skills in German are needed
• working permission European Union/Germany

Our offer:

• A diverse, interesting, and responsible role
• A young, dynamic, collegial, and international team dedicated to addressing urgent medical needs
• Opportunities to apply theoretical knowledge in practice and gain valuable experience
• Insight into the exciting field of medical device development and regulatory requirements
• Competitive salary and benefits
• Continuous professional development to stay updated with regulatory standards
• 30 d of vacation per year

Applicants from abroad are welcome!

Please send your detailed application, including cover letter, resume, and certificates to info@deviemedical.com.