Boston Scientific Principal R&D Engineer 

Canada, Ontario, Mississauga 

404766778

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.

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.

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.

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.

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.

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.

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:

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

Preferred qualifications:

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

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

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