
R&D Engineer I (Contract)
- Mississauga, ON
- $49,700 per year
- Permanent
- Full-time
- Fully participate in project teams to contribute the necessary technical work related to product design and development.
- Technical analysis of medical device systems and materials for existing products to ensure designs meet quality and regulatory standards.
- Assist in DFM (Design for Manufacturing) activities and work cross-functionally with Quality, Sourcing and Process/Manufacturing counterparts.
- Investigate failure modes and perform root cause analyses.
- Generate detailed engineering documentation (e.g. Technical reports, DHF, and DMR) in adherence to quality policies and systems.
- Comply with the Health & Safety policies of the company and inform Management of unsafe working conditions.
- Other duties as required.
- Bachelor's degree in Mechanical/Biomedical engineering, or equivalent
- Minimum 1-2 years related working experience, or equivalent
- Experience working within a quality management system and quality system controls (e.g. Design inputs/outputs, Verification/validation, etc.)
- Knowledge of the design requirements as per 21 CFR 820 and ISO 13485
- Candidates should be self-starters and have a hands-on approach
- Ability to work independently and within a diverse group of Engineers
- Strong communication skills (verbal/written)
- Bachelor's degree in Biomedical, Mechanical, or Electrical Engineering preferred
- Experience working within medical device industry
- Familiarity with industry-related standards (e.g. ISO, ASTM, ASME, IEC, etc.) and their direct application
- Experience with product lifecycle management
- Experience with catheter devices development