Product Engineer (Electrical)
Rogue Research Inc. is currently looking for a product engineer to join its R&D 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.
Advantages of working at Rogue Research:
- Stimulating work environment where innovation and creativity are used to develop unique tools that contribute to the advancement of medical research and improves the lives of patients.
- Offices in the Mile-Ex in the heart of the newly forming AI hub in Montreal
- Flexible work hours
Interested candidates are invited to send their cv in PDF format to email@example.com.