Innovative Medical Device Designer

2 weeks ago

Mississauga, Ontario, Canada Boston Scientific Full time

About Boston Scientific

We are a global leader in medical science, dedicated to solving the most pressing health industry challenges. Our mission is to advance science for life, improving patient outcomes and creating value for our customers.

As a company committed to innovation and excellence, we provide opportunities for employees to grow and develop their skills in a supportive and collaborative environment.

Earn an Estimated $120,000 - $150,000 per year

Our team of engineers work together to design, develop, and test new medical devices that improve patient lives. We are seeking an R&D Engineer II to join our team in Mississauga, Canada.

About the Role

  • The R&D Engineer II will work independently and collaboratively with multidisciplinary teams to develop new technologies, products, equipment, and processes.
  • This role involves compiling and analyzing data to establish technical specifications for designing or modifying products, processes, and materials.
  • The successful candidate will ensure compliance to industry and international standards, developing verification and validation plans, protocols, and reports.
  • Responsibilities include independent testing, studies, analyses, and interpretations to generate technical conclusions and provide recommendations.
  • This position also involves providing technical guidance to review work plans and advising on unusual features of projects.
  • The R&D Engineer II will participate in failure investigations and repair planning, assisting in DFM (Design for Manufacturing) activities, and developing and testing new manufacturing processes.
  • This role also supports regulatory filings to various government bodies as required, and contributes to the development of intellectual property where necessary.
  • The ideal candidate will have 3+ years of related working experience from a regulated manufacturing industry, and 2+ years of relevant design control experience.
  • A Bachelor's Degree in Engineering (Electrical, Biomedical preferred) is required for this position.

Required Skills and Qualifications

  • Bachelor's Degree in Engineering (Electrical, Biomedical preferred)
  • 3+ years of related working experience from a regulated manufacturing industry
  • 2+ years of relevant design control experience

Preferred Qualifications

  • Experience focusing on R&D activities relating to Electro-mechanical equipment in the medical devices industry
  • Knowledge of ISO 13485, ISO 14971, 21 CFR part 820, ISO 11135 and ISO 11607
  • Experience with systems and electrical/software design and test
  • Experience with IEC 60601-1 and collateral standards
  • Self-starter with the ability to quickly learn about new processes
  • Excellent analytical and communication skills (both written and oral)

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