Senior R&D Engineer

Additional Locations: Canada-ON-Mississauga; Canada-ON-Toronto

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

As a Senior R&D Engineer, you will play a key technical leadership role in the development, enhancement, and lifecycle management 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. This role requires strong cross-functional collaboration, strategic problem-solving, and technical expertise in medical device engineering within a regulated environment. You will lead investigations, drive improvements, support regulatory submissions, and provide mentorship to junior team members, while also contributing to new value improvement initiatives.

Your responsibilities will include:

• Conduct complex failure analyses and recommend design or process improvements.
• Independently plan and execute technical tasks and documentation, ensuring compliance with internal and international standards.
• 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.) and device master records (DMR)
• Interface with suppliers, supply chain, and manufacturing teams to facilitate the integration of complex components into the overall system.
• Support pre-clinical and clinical research activities, ensuring that system-level performance is validated in real-world scenarios.
• Support regulatory filings to various government bodies, ensuring compliance with applicable standards and regulations.
• Identify opportunities and support development of intellectual property.
• Provide mentorship and technical guidance to junior engineers and technicians.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Other duties as required.

Required Qualifications:

• Bachelor's degree in biomedical engineering, mechanical engineering, electrical engineering, systems engineering, or a related field.
• 5+ years of relevant experience in a regulated medical device environment
• Proven expertise in product development lifecycle, including design, testing, and risk analysis
• Knowledge of design requirements as per ISO 13485 and other relevant regulatory standards.
• 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.
• Excellent organizational, communication, and collaboration skills, with the ability to contribute effectively to team objectives.

Preferred Qualifications:

• Related experience in the development of Medical Electrical Systems in the medical device industry
• Experience with IEC and collateral standards 
• Experience with IEC 62304 
• Experience with Medical Device Cybersecurity
• Experience with leading more junior engineers

Learn more about our Transseptal Access Devices

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Requisition ID: 620566

Minimum Salary: $79700 

Maximum Salary: $158200 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for hourly, non-sales roles may 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 for salaried, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

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

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you