Product Specialist

About the job

About us

We design and manufacture innovative medical devices based on optical fibre, used in phototherapy and 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 to strengthen the robustness of our regulatory activities, we are undertaking a gradual transition to the use of artificial intelligence (AI) tools to improve our quality processes and the management of our technical files.

We are looking for a microtechnology engineer ready to play a key role in this evolution.

Contract type: Permanent contract

Your mission

1. Complete management of technical files (main task)

• 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 service and quality control

1. Support 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 support the company in its evolution by using AI to:

• Improve the drafting, consistency and harmonisation of quality documents
• Automatically extract key data (tests, reports, validations)
• Help identify inconsistencies or missing elements in technical files
• Contribute to the early stages of multi-country document automation

Profile sought

• HES or EPF engineer in microtechnology or equivalent
• English and French, spoken and written, level C1
• Experience in an ISO 13485 environment or other regulated industry = major asset
• Comfortable 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 opportunity to train in AI tools for document management
• A high-tech environment and close proximity to R&D
• A dynamic and caring corporate culture

To apply

Contact: Mrs Valérie Proust

Subject: Application – Product Specialist