Sep 13, 2021
$80,000 - $100,000 yearly
Lachine, Montreal, QC, Canada
Dymedso is looking for a medical device engineer to join our growing team in Lachine. The new hire will be part of a small engineering team and will be able to work on multiple projects and various aspects of the products. With a large spectrum of tasks related to product development, prototyping, testing, certification & production, the person will have the opportunity to apply its engineering skills to different sectors in the company.
- ISO 13485
- Write & maintain engineering standard operating procedures
- Lead the Risk Management Team in the conduct and documentation of process risk analyses
- Supporting engineering & production change control activities, including maintenance of Control Plans
- Write and manage ECRs (Engineering change requests)
- Corrective and Preventive action leadership (CAPA) including root cause analysis and action plans
- Manage & organize R&D/Production’s electronic documentation
- IEC 60601
- Participate in device pre-testing activities in-house or in-labs
- Participate in test plans elaboration for lab testing certification
- Testing labs interactions
- Lead the effort required to requests for amendments on current certifications
- Help in establishing certification strategies for multiple countries support
- Medical device certifications
- Understand and guide through the different submission process (FDA, Health Canada & CE)
- Prepare & review required documentation for submission
- Manage submission and interact with certification authorities
- Participate in the definition of requirements, design plan & design reviews
- Develop medical device verification and validation test protocols for new products and existing products that are affected by design change.
- Identify product failure symptoms, work with design engineers, project team leads and immediate supervisor to identify root cause.
- Prepare final test reports, provide critical updates and manage documentation meticulously.
Position Qualifications Required
- Ability to work in a french & english environment
- Master’s degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering, Electrical Engineering or equivalent
- 2-5 years of experience in medical devices
- Able to collaborate in a team environment across departments including quality, finance, supply chain, scheduling, customer service, and various engineering teams
- Must be self-directed, dependable, and motivated with excellent relationship and time management skills
- Solid team leadership skills
- Decision making and problem solving abilities
- Demonstrated effective interpersonal and communication skills, including written communication.