Senior Process Engineer

4 weeks ago

Mississauga, Ontario, Canada Boston Scientific Full time

About the Role

We are seeking a highly skilled Senior Process Engineer to join our dynamic Process Development Team at Boston Scientific. As a key member of our team, you will play a critical role in shaping the future of medical device manufacturing.

Key Responsibilities

  • Lead the research, development, and evaluation of mechanical materials, components, and processes to drive technology forward.
  • Conduct feasibility studies to verify the capability and functionality of new designs and processes, ensuring they meet the highest standards.
  • Apply technical expertise to innovate, design, and develop new processes, procedures, and automation that enhance manufacturing capabilities.
  • Review and coordinate vendor activities to ensure seamless integration and support for development projects.
  • Utilize expertise in machine design principles and CAD modeling to create and communicate complex technical drawings and presentations.
  • Design and execute experimental plans to drive data-based decisions, leading to product and process improvements.
  • Work closely with subject matter experts 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 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 to meet quality system requirements.
  • Adhere to all requirements of the Quality Management System, demonstrate company values, and comply with Health & Safety policies.

Requirements

  • 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.

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