Senior R&D Engineer

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

As a Senior R&D Engineer, you will play a key technical leadership role in the support, enhancement, and lifecycle management of our transseptal product portfolio. 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.

• Evaluate and redesign existing product components or systems, and lead verification and validation activities for sustaining engineering initiatives.

• Independently plan and execute technical tasks and documentation, ensuring compliance with internal and international standards.

• Develop and maintain product design history files (DHF), device master records (DMR), and risk management documentation (FMEA, PFMEA, hazard analyses).

• Interface with suppliers, supply chain, and manufacturing teams to drive design for manufacturability (DFM), cost savings, and continuous product improvements.

• Contribute to project planning, providing expert-level technical input and oversight.

• Provide mentorship and technical guidance to junior engineers and technicians.

• Participate in pre-clinical and clinical support activities, as well as regulatory submissions.

• Support post-market surveillance and field request resolution.

• Identify opportunities and support development of intellectual property.

• Perform all duties in compliance with applicable quality and regulatory standards.

Required qualifications:

• Bachelor’s degree in mechanical or biomedical engineering (or equivalent).

• 5+ years of relevant experience in a regulated medical device environment.

• 4+ years of hands-on experience with design controls.

• Proven expertise in product development lifecycle, including design, testing, and risk analysis.

Preferred Qualifications

·      

• Experience with transseptal systems, guidewires, or catheter-based technologies.

• Knowledge of medical device regulations and standards: ISO 13485, ISO 14971, 21 CFR Part 820, ISO 11135, and ISO 11607.

• Experience in rapid design iteration, technical troubleshooting, and process improvement.

• Strong statistical analysis skills and familiarity with DOE.

• Demonstrated ability to work independently and lead within multidisciplinary teams.

• Excellent verbal and written communication skills.

• Strong interest in biomedical innovation and product performance improvement.

• Ability to work in a high-paced, collaborative environment with shifting priorities.

Learn more about our Transseptal Access Devices 

Click this link to explore the groundbreaking technology behind our transseptal access devices at Boston Scientific: Transseptal access devices.

Requisition ID: 606937

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 www.bscbenefitsconnect.com--will 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!