Medical Device EngineerAbout usWe design and produce innovative medical devices based on fiber optics, used in phototherapy, and in a medium-sized Swiss company that is part of a group (Rakuten Medical Inc) and markets its products worldwide. As part of our growth and to strengthen the robustness of our regulatory activities, we are gradually transitioning to artificial intelligence (AI) tools to improve our quality processes and the management of our files. We are looking for a microtechnology engineer ready to play a key role in this transition.Main tasks: 1. Complete management of technical files (main mission)- Structure, update, and maintain Technical Files in accordance with the European MDR regulation.- Maintain the Design History Files (DHF) and the design documentation.- Prepare necessary elements for compliance in Switzerland (ODim), USA (FDA 21 CFR 820), and Japan (PMDA).- Gather data from production, R&D, clinical service, and quality control.2. Support for quality activities- Participate in the writing and updating of SOPs, forms, and instructions.- Contribute to internal and external audits (ISO, notified bodies, FDA, PMDA).3. Active involvement of AI in processesYou will assist the company in its evolution by using AI to:- Improve the writing, coherence, and quality of documents.- Extract key data (tests, reports).- Help identify inconsistencies or missing elements in technical files.- Contribute to the early stages of multi-country documentation.Profile sought- HES or EPF engineer in microtechnology or equivalent.- English and French, oral and written, level C1.- Experience in an ISO environment or other regulated industry = major asset.- Comfort with structured documents, analysis, and quality processes.- Basic knowledge of MDR or FDA requirements = a plus.- Interest in digital tools and AI.What we offer- A key role in the multi-country compliance of our medical devices.- The opportunity to train in AI tools for document management.- A high-tech environment with close proximity to R&D.- A dynamic and caring company culture.To applyContact: Ms. X: – Medical Device Engineer jidc5fbaafaen jit0311aen jpiy26aen