offres d'emplois AXEPTA SA

Contribute to the design and development of new products
Coordinate multiple projects simultaneously
Interact with the different departments of the company, intervening in the different stages of the projects, from design to product launch
Contribute to the maintenance of existing product lines
Ensure compliance with applicable regulatory requirements ISO 13485, 21CFR Part 820 and MDR 2017/745 (EU)
You will be responsible for prototyping and manufacturing test devices in collaboration with internal and external manufacturers
Establish test plan, execute or monitor tests
Contribute to the design transfer of new products
Write all associated documentation, perform risk analysis and design verification/validation master plan in accordance with regulatory and quality requirements
Manage the design history file (DHF) for the project

Your profile:

Mechanical engineering degree or equivalent with a minimum of 5 years of experience as a project manager in R&D in the Medical Device industry
Experience in implantable Class III Medical Devices mandatory
Knowledge of standards and regulations associated with medical devices such as ISO 13 485, 21CFR Part 820 and MDR 2017/745 (EU)
Knowledge/experience with SolidWorks is a plus
Fluent in English and French

Research and Development Project Manager