Senior R&D Systems Engineer Job Mississauga area,Ontario Canada,Engineering

Additional Locations: Canada-ON-Mississauga

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role

We are seeking a Senior R&D Systems Engineer to play a key role in the development of our innovative medical devices. This position offers the unique opportunity to integrate systems engineering principles into the development process, ensuring that all components work harmoniously to meet regulatory and clinical requirements. You will collaborate with government bodies to obtain regulatory approval and work with the IP department to issue patents, contributing to innovative solutions in the medical device sector.

Your Responsibilities Will Include:

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.

Required Qualifications:

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.

Preferred Qualifications:

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.


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