Design Assurance Engineer III

1 month ago


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

At Boston Scientific, we're committed to advancing science for life by developing innovative medical solutions that improve patient lives. As a Design Assurance Engineer III, you'll play a critical role in ensuring the quality and safety of our medical devices.

Responsibilities
  • Design control and risk management of next-generation capital equipment devices
  • Use clinical knowledge and data to influence device testing and design
  • Implement and develop product risk management tools, such as Hazard Analysis, Fault Tree, and FMEAs
  • Maintain compliance to all quality requirements and ensure quality into all aspects of work
  • Plan, organize, and prioritize daily work routine to meet established schedule
  • Utilize standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities
  • Apply technical skills, including sound, systematic problem-solving methodologies, to identify, prioritize, communicate, and resolve quality issues
Requirements
  • Bachelor's Degree in Engineering (Electrical, Biomedical preferred)
  • 3+ years related working experience from Medical Device Industry
  • Knowledge of ISO 13485, ISO 14971, IEC 62366-1, IEC 62304
  • Demonstrated interpersonal skills with ability to work within a team environment
  • Strong written/verbal communication skills
  • Ability to work independently under limited supervision


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