Product Specialist

• 19 août 2026
• 100%
• Indefinite duration
• English (Fluent), French (Fluent)
• Chemin des Larges-Pièces 6, 1024 Ecublens VD
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About us

We design and produce innovative medical devices based on fiber optics, 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 undertaking 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

1. Complete 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, clinical services and quality control

1. 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)

1. 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
• Ease 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-technology environment and close proximity to R&D
• A dynamic and benevolent corporate culture

To apply

Contact: Madame Valérie Proust

Subject: Candidature - Product Specialist