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Design Assurance Engineer I

2 months ago


Mississauga, Ontario, Canada Boston Scientific Full time

About the Role:

Boston Scientific is seeking a highly skilled Design Assurance Engineer I to join our Quality team. This position plays a critical role in ensuring the development and maintenance of medical devices meet internal and external requirements.

Your Key Responsibilities:

  • Collaborate with cross-functional teams to identify and implement effective controls to support product development and maintenance.
  • Develop a deep understanding of Design Controls, Risk Management, and Usability for Medical Devices.
  • Apply repeatable problem-solving concepts to drive quality and compliance.
  • Stay up-to-date with industry standards and best practices.
  • Support departmental, functional, and divisional design quality goals and priorities.
  • Ensure compliance to all quality requirements by maintaining a strong focus on quality throughout all aspects of work.
  • Participate in various design quality assurance and compliance improvement projects.
  • Perform other duties as necessary or required by the organization.

Required Qualifications:

  • Bachelor's degree in Biomedical Engineering, Mechanical, Electrical Engineering, or a related field of study.
  • At least 1 year of related work experience from the Medical Device Industry.
  • Demonstrated interpersonal skills with the ability to work within a team environment.
  • Strong written and verbal communication skills.
  • Ability to travel (less than 25%).

Preferred Qualifications:

  • Knowledge of Six Sigma problem-solving methodologies.
  • Understanding of ISO 13485, ISO 14971, and IEC 60601 standards.
  • Experience in medical imaging.