A company is looking for a development engineer who works on surgical instrument design and supports regulatory submissions at international authorities. The goal is to develop innovative medical products and meet their regulatory requirements. The role requires close collaboration with various teams and hands-on lab work.
- Development of instruments for surgical applications and support for approvals in the EU (MDR, IEC 60601), the USA (FDA), and other international markets.
- Conducting application tests on animal tissue as well as technical tests for standard compliance and documenting the results.
- Lab work, including evaluating instrument compatibility with generators, setting parameters on own generators, and handling customer complaints.
- Creating technical documentation for medical devices, taking into account technical and regulatory requirements.
- Defining product requirements for instruments, generators, and systems in collaboration with systems engineering and verification.