Senior Process Engineer
Boston Scientific View all jobs
- Mississauga, ON
- $83,300 per year
- Permanent
- Full-time
- Lead research, development, design, and evaluation of materials, components, assemblies, and processes that advance our technology and product portfolio.
- Conduct feasibility studies and detailed engineering assessments to verify new designs, processes, and technologies.
- Apply structured problem solving, lean principles, and best-practice process development to drive product and process improvements.
- Work closely with subject matter experts, R&D, and Quality teams to enhance manufacturing capabilities, develop concepts and influence design for manufacturability
- Plan, implement, and coordinate new product introductions, including product and process design, specifications, validations, equipment layout, production procedures, and procurement of materials.
- Design and introduce new manufacturing processes, automation, and equipment to increase capabilities and efficiencies, delivering a competitive edge to our company and customers.
- Develop and own critical processes for complex devices in pilot and production environments, ensuring robust and capable operations.
- Design and execute structured experimental plans for data-based decision-making and continuous improvement.
- Provide technical leadership and mentorship to technicians and entry-level engineers.
- Lead and organize technical reviews, communicate technical updates to stakeholders, and manage cross-functional project deliverables related to Project Management, PDP/TDP, and Quality Systems.
- Drive and support intellectual property generation and submissions related to product and process innovation.
- Thrive in non-routine situations with high levels of ambiguity, working independently to resolve technical challenges and deliver results.
- Develop, write, and review process validation strategies and related deliverables (e.g., experiment tech reports, GR&R, TMV, IQ, FMEA) to meet quality system requirements.
- Adhere to all Quality Management System requirements, demonstrate company values, and comply with Health & Safety policies, promptly reporting unsafe working conditions.
- Occasional travel may be required, up to 15%.
- Bachelor's degree in Engineering or a related engineering field (Mechanical, Biomedical, Electrical, or Mechatronics preferred)
- 5+ years of relevant work experience
- Experience in process design/development and product design for manufacturability, preferably in the medical device industry
- Strong knowledge of manufacturing processes, materials, and technologies
- Experience with process validation, process FMEA, project management, and lean manufacturing principles
- Strong root cause analysis, analytical, organizational, communication (written and oral), and collaboration skills
- Solid experimental design and statistical analysis knowledge
- Proficient in MS Office
- Experience in the medical device industry or other regulated sectors
- Expertise in process development, process characterization, and overall validation processes
- Lean or Six Sigma training desired
- Strong analytical skills in business needs assessment and solution implementation