Boston Scientific Senior Process Engineer - Electrophysiology 

Canada, Ontario, Mississauga 

78426950

Canada-ON-Toronto; Canada-ON-Mississauga

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
  

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.