Boston Scientific Senior R&D Systems Engineer 

Canada, Ontario, Mississauga 

400955182

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.

Maximum Salary: $158200

Compensation forhourly, non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forsalaried, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

Compensation for
sales rolesis governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).

This job involves regular collaboration with colleagues, clients, and stakeholders across Canada, the U.S., and/or internationally, making proficiency in English essential for effective communication and alignment. English is necessary for engaging with a range of documentation and maintaining effective communication if interacting with external clients or vendors.

As detailed in the job description, this job involves communicating, both verbally and in writing, with other Boston Scientific teams located across Canada, the United States and/or with our international clients and partners. International customers and partners represent an important part of our activities. Based on an evaluation, we have determined that the duties of Senior R&D Systems Engineer position require knowledge of English in addition to French (oral and written). We also determined that the English language skills already required of other employees do not permit the performance of English language skills tasks related to Senior R&D Systems Engineer position.

However, in Québec, Boston Scientific limits as much as possible the number of positions for which it requires the knowledge of another language than French. Boston Scientific solely requires proficiency in English where it is necessary for the performance of an employee’s duties.