Ihre Aufgaben:
* Design and develop custom-made and off-the-shelf implants, from concept to release
* Collaborate directly with surgeons and clinical partners to translate anatomical and functional requirements into implant designs
* Create and optimize CAD models, engineering drawings, and 3D printed prototypes
* Prepare and maintain design documentation (Design History Files, risk management files, usability reports, test plans, and verification documentation)
* Support design control and usability engineering activities in compliance with ISO 13485, ISO 14971, and FDA 21 CFR Part 820
* Conduct design reviews, verification, and validation activities
Ihre Qualifikationen:
* University degree in Biomedical Engineering or a related field
* Familiarity with design control, usability engineering, and relevant regulatory standards (ISO 13485, ISO 14971, FDA 21 CFR Part 820)
* Strong proficiency in Rhinoceros 3D; experience with automation or scripting (e.g., Python, Grasshopper) is a plus
* Strong communication and teamwork skills, with experience collaborating with clinical partners
* Fluent in English (written and spoken); German is an advantage
Ihre Vorteile:
* A highly motivated team and an open way of communication
* Continuous support during the assignment