Design Assurance Engineer III

2 months ago


Mississauga, Ontario, Canada Boston Scientific Full time

About the Role

We are seeking a highly skilled Design Assurance Engineer III to join our Design Assurance team at Boston Scientific. This position plays a critical role in ensuring the quality and safety of our medical devices.

Key Responsibilities

  • Develop and implement design control and risk management strategies for next-generation capital equipment devices.
  • Utilize clinical knowledge and data to inform device testing and design.
  • Design and implement product risk management tools, such as Hazard Analysis, Fault Tree, and FMEAs.
  • Maintain compliance with quality requirements and regulations, including ISO 13485 and ISO 14971.
  • Collaborate with cross-functional teams to identify and resolve quality issues.
  • Apply technical skills and problem-solving methodologies to ensure product safety and quality.

Requirements

  • Bachelor's Degree in Engineering (Electrical, Biomedical preferred).
  • 3+ years of experience in the medical device industry.
  • Knowledge of ISO 13485, ISO 14971, IEC 62304, and other relevant regulations.
  • Strong written and verbal communication skills.
  • Ability to work independently and as part of a team.

Preferred Qualifications

  • Experience with Six Sigma problem-solving methodologies.
  • Training in FDA regulations or ISO standards.

About Boston Scientific

Boston Scientific is a global leader in medical science, committed to solving the challenges that matter most. We are united by a deep caring for human life and a mission to advance science for life. Our values of diversity, innovation, and collaboration drive our work to create innovative medical solutions that improve patient lives.



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