Principal 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:

We are seeking a dynamic and experienced Principal R&D Engineer to lead the development and enhancement of cutting-edge medical devices. This role offers the opportunity to drive innovative solutions, collaborate with cross-functional teams, and ensure product designs meet the highest quality and regulatory standards. The ideal candidate will combine technical expertise with leadership skills to deliver impactful results.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our local office at least three days per week.

Your responsibilities will include:

1. Technical Leadership
   • Lead and direct project teams, ensuring successful execution of technical work related to product design and development.
   • Provide technical and professional guidance to team members, fostering a culture of innovation and excellence.
   • Drive the technical analysis of medical device systems and materials for new and existing products, ensuring compliance with quality and regulatory standards.
2. Design and Development
   • Gather and analyze requirements from internal and external stakeholders to capture user needs and translate them into actionable product designs.
   • Innovate and create new product concepts and designs, contributing to the company's IP portfolio through invention disclosures and patent applications.
   • Assist in Design for Manufacturing (DFM) activities to ensure seamless scalability of designs.
3. Problem-Solving and Compliance
   • Lead investigations into failure modes and perform root cause analyses to address technical challenges.
   • Ensure compliance with relevant regulatory requirements and standards throughout the product lifecycle.
4. Cross-Functional Collaboration
   • Engage in discussions with cross-functional and cross-team stakeholders to drive results and execute activities efficiently.
   • Leverage organizational resources to identify and implement new capabilities and solutions.
   • Develop and maintain strong relationships with internal stakeholders, healthcare professionals, and suppliers.
5. Documentation and Reporting
   • Present project updates, technical insights, and strategic recommendations to senior management.
   • Review engineering documentation, including technical reports, DHF (Design History File), and DMR (Device Master Record), ensuring adherence to quality systems and policies.
6. Innovation and Industry Engagement
   • Monitor industry trends and technological advancements to identify opportunities for innovation and improvement.
   • Contribute to the company's strategic initiatives by developing creative solutions that address market needs and challenges.
7. General Responsibilities
   • Ensure adherence to the company's health and safety policies, reporting unsafe working conditions when identified.
   • Ability to work effectively in an inclusive, collaborative, and fast-paced environment with minimal direction.
   • Travel domestically and internationally (approximately 10%) as required.
   • Perform other duties as needed to support organizational goals.

Required qualifications:

1. Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field
2. Minimum 8 years related working technical experience
3. Experience working within a quality management system and quality system controls (e.g. Design inputs/outputs, Verification/validation, etc.)
4. Knowledge of the design requirements as per 21 CFR 820 and ISO 13485
5. Candidate should be a technical leader, self-starters and have a hands-on approach
6. Ability to work independently and within a diverse group of Engineers
7. Strong communication skills (verbal/written)

Preferred qualifications:

1. Experience working within medical device R&D departments, with hands-on prototyping and testing
2. Knowledge of cardiac applications
3. Experience with catheter devices development
4. Familiarity with industry related standards (e.g. ISO, ASTM, ASME, IEC, etc.) and their direct application

Requisition ID: 596689

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see bscbenefitsconnect - 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.

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 uphold those values in 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 and look forward to connecting with you!