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Design Assurance Engineer

2 months ago


Mississauga, Ontario, Canada Boston Scientific Full time

About Boston Scientific

At Boston Scientific, we empower individuals to make a difference in the world of healthcare by working collaboratively with diverse and high-performing teams. We tackle some of the most significant challenges in the industry, providing access to cutting-edge tools, information, and training to foster professional growth and development.

About the Role

We are expanding our Quality team and seeking a talented Design Assurance Engineer to contribute to our mission. This role involves close collaboration with New Product Development teams to ensure robust risk management strategies, comprehensive design controls, and effective production and process controls.

Your Responsibilities

  • Collaborate within a team to establish and implement efficient controls that support the development and maintenance of products, ensuring compliance with internal and external requirements.
  • Develop a thorough understanding of Design Controls, Risk Management, and Usability principles specifically applied to Medical Devices.
  • Apply proven problem-solving methodologies to address challenges effectively.
  • Stay informed about industry best practices and evolving standards.
  • Contribute to departmental, functional, and divisional design quality goals and priorities.
  • Integrate quality into all aspects of work by adhering to all quality requirements.
  • Participate in various design quality assurance and compliance improvement projects.

Required Qualifications

  • Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field of study.
  • One or more years of relevant work experience within the Medical Device Industry.
  • Demonstrated interpersonal skills with the ability to thrive in a team environment.
  • Excellent written and verbal communication skills.
  • Ability to travel occasionally (less than 25%).

Preferred Qualifications

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