R&D Engineer II

4 weeks ago


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

The R&D Engineer II will play a key role in developing new medical technologies, products, and equipment with minimal supervision. This individual will be responsible for compiling and analyzing operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.

Responsibilities
  • Support the development of complex 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, including ISO 13485 and 21 CFR part 820.
  • 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.
  • Provide technical input into project-level planning 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 and 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.
Requirements
  • 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
  • Experience with the overall design and development process
Preferred Qualifications
  • Experience focusing on R&D activities relating to Electro-mechanical equipment in the medical devices industry
  • Knowledge of 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)
  • Able to work independently and in a multidisciplinary team environment

Boston Scientific is a leader in medical science, committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. If you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you.


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