Process Engineer III

1 month ago

Mississauga, Ontario, Canada Boston Scientific Full time
About the Role

Boston Scientific is seeking a highly motivated and experienced engineer to work on process development for design and commercialization of new technologies across BSC. The candidate must have a desire to utilize their skills to solve technical/complex problems in a hands-on manner, working in a fast-paced environment, and across multiple functions in a global company.

Key Responsibilities
  • Develop functional deliverables associated with the TDP/PDP, Project Management and Quality Systems, including Master Validation Plan, Process Risk Assessment, Validation Protocols, Reports, BOMs and Routers.
  • Prepare and present technical data and recommendations at technical reviews.
  • Provide Design for Manufacturability (DFM) input.
  • Work with Senior Process Engineers in designing and executing experiments for process optimization.
  • Assess process capabilities, prioritize process improvement opportunities, and innovate and implement process improvements on multiple and moderately complex processes.
  • Apply technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
  • Contribute ideas to or generate Intellectual Property submissions.
  • May serve as a core team lead or extended team member.
  • May supervise and/or mentor engineers with the team.
Requirements
  • BS in Mechanical Engineering or Biomedical Engineering (or related degree) with Mechanical background and 5+ years of process development experience.
  • Demonstrated use of DOE and problem solving.
  • Demonstrated ability to develop processes from concept to production.
  • Demonstrated knowledge and application of Processes and Equipment validation techniques (IQ, OQ, PQ), PRA and associated regulatory requirements.
Preferred Qualifications
  • Demonstrated cross functional teamwork in technically demanding environment.
  • Highly motivated individual that can independently drive deliverables to completion through collaboration among team members.
  • Demonstrated ability to develop and drive innovative solutions into processes and products.
  • Expertise in New Product Development.
  • Medical device or other regulated industry experience.
  • Process Development; equipment validations and process characterization and validation experience.
  • Demonstrated understanding and usage of statistics to drive improvements.
  • Experience working with plastics, metals and various joining methods.
  • Open to travel of up to 10% of their time.

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