DESIGN TRANSFER ENGINEER

Overview

A Design Transfer Engineer plays a critical role in bridging the gap between product development and manufacturing. He ensures that medical device designs are successfully transferred from R&D into scalable, compliant, and efficient production processes.

Responsibilities

• Lead and coordinate design transfer activities from R&D to manufacturing for new medical devices and then product updates.
• Develop and execute Design Transfer Plans in accordance with ISO 13485, FDA QSR, and EU MDR requirements.
• Manage a Design transfer process that guarantees a fluid transition from development to production.
• Collaborate with cross-functional teams including R&D, Quality, Regulatory, and Operations to ensure smooth transition to production.
• Define manufacturing specifications, work instructions and verification protocols from design outputs.
• Build the BOM in collaboration with R&D and operation.
• Perform the training of manufacturing operators to the work instructions.
• Develop manufacturing tools when required and participate to their validation.
• Conduct risk assessments related to manufacturing process and ensure mitigation strategies are implemented.
• Ensure documentation is complete, accurate, and compliant for regulatory submissions, audits and inspections.

Who you are

• Education: Engineering/Master's degree in Mechanical, Biomedical or Industrial Engineering or equivalent.
• Experience: at least 5 years of experience in Design transfer, manufacturing engineering or product development.
• Strong knowledge of design controls, ISO13485, FDA 21 CFR, EU MDR.
• Organized, rigorous, and autonomous, project management skills.
• Excellent communication skills in English and French.
• Proficiency in CAD tools, ERP systems and documentation tools.
• Enthusiasm and a strong desire to enhance surgical technology to improve the life of patients.
• A proactive personality with the ability to integrate with the existing start-up team. Ability to listen and be a team player.
• Able to learn and adapt quickly to a rapidly evolving work environment.