R&D Engineer II

1 week ago


Mississauga, Ontario, Canada Boston Scientific Full time

About the Role:

This role is part of the R&D Engineering team within the Access Solutions division at Boston Scientific. The team is responsible for new product development projects, from concept generation to manufacturing transfer. As a member of this team, you will work collaboratively with other engineers and supporting departments to compile, analyze, and report operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.

Your Responsibilities Will Include:

  • Participating in project teams to contribute technical work related to product design and development.
  • Conducting technical analysis of medical device systems and materials for new product development and existing products to ensure designs meet quality and regulatory standards.
  • Gathering requirements from internal and external sources to accurately capture user needs and ensure products meet them.
  • Investigating failure modes and performing root cause analyses.
  • Generating detailed engineering documentation (e.g. Technical reports, DHF, and DMR) in adherence to quality policies and systems.
  • Innovating and creating new concepts and designs for products and submitting invention disclosures.
  • Assisting in Design for Manufacturing (DFM) activities.
  • Complying with the health and safety policies of the company and informing management of unsafe working conditions.
  • Other duties as required.

Required Qualifications:

  • Bachelor's degree in Biomedical engineering, or equivalent.
  • Minimum 2 years related working experience, or equivalent.
  • Experience working within a quality management system and quality system controls (e.g. Design inputs/outputs, Verification/validation, etc.).
  • Knowledge of the design requirements as per 21 CFR 820 and ISO 13485.
  • Candidates should be self-starters and have a hands-on approach.
  • Ability to work independently and within a diverse group of Engineers.
  • Strong communication skills (verbal/written).

Preferred Qualifications:

  • Bachelor's degree in Biomedical, Mechanical, or Electrical Engineering preferred.
  • Experience working within medical device R&D departments, with hands-on prototyping and testing.
  • Knowledge of ultrasound imaging, particularly in cardiac applications.
  • Familiarity with industry-related standards (e.g. ISO, ASTM, ASME, IEC, etc.) and their direct application.
  • Experience with catheter devices development.
  • Experience with injection molding component design.
  • Experience with electrical medical device testing and development.


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