Our customer is a well-established medical equipment manufacturer for over 20 years. Its state-of-the-art equipment is used in laboratories and research centers around the world. They are currently looking for a Product Engineer to play a key role in the team.

The product engineer will work closely with the product development and production teams on several medical device projects simultaneously. More precisely, the product engineer will be responsible to:

- Write and update specification documents for different medical device projects.
- Perform literature reviews to have a better understanding of the different applications of similar products on the market.
- Review applicable standards (IEC, MDSAP) and ensure that they are taken into consideration in specifications and other documents.
- Plan, write and maintain risk analysis documentation related to medical devices.
- Define and maintain project schedules.
- Manage certification projects (IEC) and coordinate with certification laboratories.
- Assist engineering in the development of verification protocols and their execution (e.g. includes verification of printed circuit boards).
- Coordinate transfer to production of new medical devices.
- Prepare, manage and review device history files (DHR).
- Make sure quality system processes are followed during design and production activities.
- Write, review and maintain assembly and verification instructions related to electrical components.
- Manage the review, investigation and update of nonconformity reports and correction plans from production (related to electrical aspects).
- Follow-up on component availability and plan required changes with engineering.
- Assist engineering in manufacturing prototypes.

- Engineering in Electrical engineering or equivalent.
- Excellent writing skills.
- Ability to read and understand electrical schematics.
- Experience with measuring tools such as oscilloscopes.
- Experience in SMT soldering.
- Detail oriented.
- Autonomous et proactive.
- Bilingual (English and French).
- Knowledge of IEC 60601 standards.
- Experience in an ISO 13485/MDSAP work environment.
- Interest and/or experience in the biomedical field.

- Competitive salary between $65,000 and $80,000 depending on experience.
- RRSP.
- Annual bonus based on company performance.
- Insurance.
- Flexible and innovative work environment.