Product Specialist

Product Specialist About us We design and produce innovative medical devices based on optical fiber, used in phototherapy and in minimally-invasive applications. Our Swiss, human-sized company is part of an international group (Rakuten Medical Inc) and markets its products worldwide. As part of our growth and in order to strengthen the robustness of our regulatory activities, we are engaging in a progressive transition towards the use of artificial intelligence (AI) tools to improve our quality processes and the management of our technical files. We are looking for a microtechnics engineer ready to play a key role in this evolution. Contract type: CDI Your mission Full management of technical files (main mission) Structure, update, and maintain Technical Files in accordance with the European MDR regulation Maintain Design History Files (DHF) and design documentation Prepare the necessary elements for Swiss compliance (ODim), USA (FDA 21 CFR 820), Japan (PMDA). Gather data from production, R&D, the clinical service, and quality control Support for quality activities Participate in the drafting and updating of SOPs, forms, and instructions Contribute to internal and external audits (ISO 13485, notified bodies, FDA, PMDA) Active participation in the integration of AI into processes You will accompany the company in its evolution by using AI to: Improve the writing, consistency, and harmonization of quality documents Automatically extract key data (tests, reports, validations) Help identify inconsistencies or missing elements in technical files Contribute to the first steps of multi-country documentary automation Profile sought HES or EPF engineer in microtechnics or equivalent English and French, oral and written, C1 level Experience in an ISO 13485 environment or other regulated industry = major asset Comfort with structured documents, analyses, and quality processes Basic knowledge of MDR or FDA requirements = a plus Interest in digital tools and AI What we offer An essential role in the multi-country compliance of our medical devices The possibility to train in AI tools for document management A high-tech environment and strong proximity to R&D A dynamic and benevolent corporate culture To apply Contact: Madame Valérie Proust Subject: Candidature – Product Specialist jpidc5fbaafjm jpit0834jm jpiy26jm