Senior Medical Device Engineer

4 weeks ago

Mississauga, Ontario, Canada Boston Scientific Full time

About Boston Scientific

Boston Scientific is a global leader in medical science, dedicated to improving patient lives through innovative medical solutions. We are committed to diversity, innovation, and high performance, and we value global collaboration and a winning spirit.

Job Summary

We are seeking a highly motivated and experienced Senior Medical Device Engineer to join our dynamic R&D team. In this role, you will play a crucial part in the development of cutting-edge medical device systems, contributing to the advancement of healthcare technology.

Responsibilities

  • Provide technical leadership in the design, prototyping, testing, and modeling of innovative medical devices.
  • Ensure compliance with industry standards by developing comprehensive design history files and verification/validation plans and reports.
  • Lead engineering projects, providing guidance and mentorship to junior engineers.
  • Contribute to failure investigations, DFM activities, and the implementation of new manufacturing processes.
  • Support regulatory filings and intellectual property development initiatives.
  • Collaborate with cross-functional teams, including research scientists and clinicians, to support pre-clinical and clinical research activities.

Qualifications

  • Bachelor's Degree in Engineering (Electrical or Biomedical preferred).
  • 5+ years of experience in a regulated manufacturing environment, specifically within the medical device industry.
  • 4+ years of proven experience in design control methodologies and processes.

Preferred Qualifications

  • Experience in R&D for electro-mechanical equipment within the medical devices sector.
  • In-depth knowledge of relevant standards, such as ISO 13485 and 21 CFR part 820.
  • Expertise in systems design and testing methodologies.
  • Strong analytical and communication skills, with the ability to effectively collaborate within a team environment.

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