Sep 13, 2021

Medical Device Engineer

$80,000 - $100,000 yearly
  • Dymedso
  • Lachine, Montreal, QC, Canada
Full time Engineering Management Product Development Quality Regulatory

Job Description

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
  • R&D
    • 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.

Apply Now