Boston Scientific Senior Process Engineer - Electrophysiology 

Canada, Ontario, Mississauga 

890766467

About the role

In this role, you will contribute to the development of new technologies through research and innovation, with a strong focus on designing medical device products, manufacturing fixtures, tools, and automating equipment. If you thrive in a fast-paced environment and are eager to take on the challenge of developing and delivering cutting-edge solutions, this is the opportunity for you.

Your responsibilities will include:

• Lead the research, development, design, and evaluation of mechanical materials, components, assemblies, and processes that drive our technology forward.
• Conduct in-depth feasibility studies to verify the capability and functionality of new designs and processes, ensuring they meet the highest standards.
• Apply your technical expertise to innovate, design, and develop new processes, procedures, tooling, and automation that enhance manufacturing capabilities.
• Review and coordinate vendor activities, ensuring seamless integration and support for development projects.
• Utilize your expertise in machine design principles and CAD modeling (such as SolidWorks) to create and communicate complex technical drawings and presentations.
• Design and execute structured experimental plans that drive data-based decisions, leading to product and process improvements.
• Work closely with subject matter experts (SMEs) and R&D teams to develop product concepts, influence design specifications, and provide valuable Design for Manufacturability (DFM) input.
• Develop and own critical processes for complex devices in a pilot environment, ensuring robust and capable operations.
• Tackle complex technical challenges in a hands-on manner, contributing to a fast-paced, innovative work environment.
• Provide structured leadership and problem-solving to drive product and process innovation, guiding the team through strategic process development cycles.
• Contribute ideas or generate Intellectual Property submissions that protect and enhance our technological advancements.
• Assess process capabilities, prioritize improvement opportunities, and implement innovative solutions for platform and derivative projects.
• Execute functional deliverables associated with Product Development Process (PDP)/Technology Development Process (TDP), Project Management, and Quality Systems, ensuring successful project outcomes.
• Organize, and conduct all aspects of technical reviews, providing clear communication and updates to stakeholders.
• Thrive in situations with a high level of ambiguity, working independently to tackle non-routine challenges and deliver results.
• Provide direction and mentorship to technicians and entry-level engineers, fostering a collaborative and innovative team environment.
• Develop, write, and review process validation strategies and related deliverables, such as experiment tech reports, GR&R, TMV, IQ, FMEA’s, etc., to meet quality system requirements.
• Adhere to all requirements of the Quality Management System, demonstrate company values, and comply with Health & Safety policies.
• Occasional travel may be required, up to 15%.

Required qualifications:

• Degree in Engineering or related Engineering field.
• 5+ years of relevant work experience
• Proficiency in CAD software and simulation tools
• Strong knowledge of manufacturing processes, materials, and techniques.
• Demonstrated ability to develop processes, fixtures and equipment from concept to production
• Strong mechanical aptitude. Fixture and equipment design or trouble shooting experience.
• Excellent organizational, communication, and collaboration skills

Preferred qualifications:

• Bachelor’s degree in Mechanical, Electrical, Mechatronics field.
• Extensive experience in the medical device industry or other regulated sectors.
• Expertise in process development, with a strong focus on equipment validation, process characterization, and overall validation processes.
• Hands-on experience with plastics, metals, and various joining methods, demonstrating a broad range of material expertise.
• Highly desirable experience in medical device manufacturing, particularly with sheaths, catheters, dilators, and similar products.
• Certified SolidWorks Professional (CSWP) with demonstrated proficiency.
• Strong analytical skills in assessing business needs, identifying effective solutions, and implementing them efficiently.
• Expert in automating systems, integrating equipment, and developing vision systems, with strong knowledge of advanced automation technologies.
• Experience selecting and sizing electro-mechanical components (servo motors, sensors, pneumatics, heaters) and motion control