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 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 with spinal products 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 ; French is an asset