
Senior R&D Systems Engineer
- Mississauga, ON
- 79.700 $ par an
- Permanent
- Temps-plein
- Assist in the design of cutting-edge medical devices through prototyping, testing, and modeling, with a focus on systems integration and performance optimization.
- Participates in project teams to translate user needs into design requirements (e.g. system, hardware, software, firmware, mechanical, electrical, interface, etc.) consisting of system/sub-system specifications.
- Develop verification & validation plans and conduct testing to ensure that all systems meet stringent safety and efficacy standards.
- Develop & maintain Design History Files (i.e. Requirements, Risk Management File, Technical Design Reviews, etc.)
- Collaborate on Design for Manufacturing (DFM) activities to ensure that designs are optimized for production efficiency and cost-effectiveness.
- Maintain strong working relationships with suppliers to facilitate the integration of complex components into the overall system.
- Support regulatory filings to various government bodies, ensuring compliance with applicable standards and regulations.
- Contribute to the development of intellectual property by identifying and protecting novel design solutions and engineering processes.
- Support pre-clinical and clinical research activities, ensuring that system-level performance is validated in real-world scenarios.
- Comply with the Health & Safety policies of the company and inform management of unsafe working conditions.
- Other duties as required.
- Bachelor's degree in biomedical engineering, mechanical engineering, electrical engineering, systems engineering, or a related field.
- 6+ years of experience with product development activities in a regulated industry, specifically in the medical device sector.
- Knowledge of design requirements as per ISO 13485 and other relevant regulatory standards.
- Hands-on experience in designing and setting up Electrical testing and equipment (Oscilloscopes, voltage/current probes, impedance analyzers, etc.)
- Experience leading rapid design iterations and making informed design recommendations based on systems-level analysis.
- Strong hypothesis-driven experimental design and statistical analysis skills to assess system performance.
- Ability to work both independently and collaboratively within a diverse group of engineers and production staff.
- Related experience in the development of multi-disciplinary products in the medical device industry
- Experience in planning and generating usability engineering deliverables
- Experience with IEC 60601-1 and collateral standards
- Experience with medical device usability
- Excellent organizational, communication, and collaboration skills, with the ability to contribute effectively to team objectives.
- Proven ability to work efficiently both as part of a team and independently.