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 60601-1 and collateral standards  Experience with IEC 62304  Experience with Medical Device Cybersecurity Experience with leading more junior engineers