R&D Innovation Specialist

3 weeks ago

Mississauga, Ontario, Canada Boston Scientific Full time

About the Role

The R&D Engineer II will develop new technology, products, equipment, and processes with minimal supervision. This role involves compiling and analyzing operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.

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.
  • Other duties as required.

Required 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
  • 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 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)
  • Able to work independently and in a multidisciplinary team environment

About Boston Scientific

As a leader in medical science for more than 40 years, we are 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.

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