Principal R&D Engineer

Boston Scientific • Toronto, ON

1d • CA$99,400 - CA$148,900

About The Position

As a Principal R&D Engineer, you will play a key technical leadership role in the support, enhancement, and lifecycle management of our Ultrasound Console and systems 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.

Requirements

• Minimum Bachelor’s degree, in Electrical, Mechanical, Systems, or Biomedical Engineering preferred
• 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.
• Extensive experience with IEC 60601-1 and IEC 60601-1-2 standards and test procedures
• Experience in leading complex hardware and software development programs.
• Extensive design experience in systems architecture and managing sub-systems development and test.
• 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.

Nice To Haves

• Experience with ultrasound imaging consoles and systems
• Knowledge of medical device regulations and standards: ISO 13485, ISO 14971, 21 CFR Part 820, ISO 11135, and ISO 11607, IEC 62304
• 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
• Experience with leading more junior engineers

Responsibilities

• Independently plan and execute technical strategy for product development and documentation, ensuring compliance with internal and international standards.
• Lead team in conducting complex failure analyses and recommend design or process improvements.
• Evaluate and redesign existing product components or systems and lead verification and validation activities.
• 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 to meet design requirements, manufacturability (DFM), cost savings, and continuous product improvements.
• Contribute to project planning, providing expert-level technical input and oversight.
• 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.
• 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.

Benefits

• The anticipated compensation 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.
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Principal