R&D Engineer III

3 days ago

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

Boston Scientific is seeking a highly skilled R&D Engineer III to join our team in Mississauga, Canada. As a key member of our Access Solutions Site, you will be responsible for leading the development of our next-generation steerable sheath for the franchise. This role will involve developing new technology, products, equipment, and processes with minimal supervision.

Key Responsibilities
  • Support complex cutting-edge medical device systems through prototyping, testing, and modeling.
  • Develop device design history files, including requirements, risk management, and usability files.
  • Ensure compliance to industry and international standards.
  • Develop verification and validation plans, protocols, and reports.
  • Perform independent tests, studies, analyses, and interpretations to generate technical conclusions and provide recommendations.
  • Conduct work across the full scope of technical and documentation activities for the department.
  • Make independent studies, analyses, interpretations, and conclusions.
  • Responsible for technical input into project-level planning.
  • Provide technical guidance to review work plans and advise on unusual features of projects.
  • Provide technical, project-level leadership to engineering assistants or junior engineering staff.
  • Participate in failure investigations and repair planning.
  • Assist in DFM (Design for Manufacturing) activities.
  • Develop and test new manufacturing processes.
  • Support regulatory filings to various government bodies as required.
  • Support the development of intellectual property where required.
  • Support pre-clinical and clinical research activities where required.
Required Qualifications
  • Bachelor's Degree in Engineering (Electrical, Biomedical preferred)
  • 4+ years of related working experience from a regulated manufacturing industry
  • 3+ years of relevant design control experience
  • Experience with the overall design and development process
Preferred Qualifications
  • Knowledge of ISO 13485, ISO 14971, 21 CFR part 820, ISO 11135, and ISO 11607
  • Self-starter with the ability to quickly learn about new processes
  • Excellent analytical and communication skills (both written and oral)
  • Able to work independently and in a multidisciplinary team environment

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