Responsibilities:
* 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, 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, 21CFR Part 820 and MDR 2017/745 (EU)
* Knowledge/experience with SolidWorks is a plus
* Fluent in English ; French is an asset
jid6624ee3a jit0729a jiy25a