Rogue Research is seeking to expand its reach into the clinical brain stimulation markets and is expanding its R&D team. We are currently looking for a new Product Engineer (ideally with mechanical design experience) to bring prototype devices to the market and/or perform continuous improvements to existing products.
- Write and update design inputs documents for different medical device projects.
- Review applicable standards (IEC, MDSAP) and ensure that they are taken into consideration in design inputs 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 manufacturing prototype devices.
- Assist engineering in the development of verification protocols and their execution.
- Review mechanical designs and update them to be “production ready”.
- Coordinate transfer to production of new medical devices.
- Prepare, manage and review device history files (DHR).
- Write, review and maintain assembly and verification instructions.
- Manage the review, investigation and update of nonconformity reports and correction plans from production.
- Make sure quality system processes are followed during design and production activities.
- Follow-up on component availability and plan required changes with engineering.
- Lead project meetings.
- 1 to 3 years of experience in the industry.
- Excellent communication and writing skills.
- Knowledge of Solidworks and/or other CAD software.
- Autonomous and proactive.
- Bilingual (English and French).
- Interest for the biomedical field.
- Experience in an ISO 13485 environment.
Interested candidates should send their CV in pdf format to the following email address :