Senior Design Assurance Engineer

4 weeks ago


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

We are seeking a highly skilled Senior Design Assurance Engineer to join our Design Assurance Quality team. In this role, you will work closely with Medical Electrical Equipment/Capital Equipment new product introduction and product life cycle teams to ensure adequate design controls are met and subsequent production and process controls are adequate.

Responsibilities
  • Responsible for design control and risk management of next-generation capital equipment devices.
  • Utilize clinical knowledge to influence how devices are tested and designed.
  • Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
  • Develop, direct, and execute plans for design control and risk management of complex projects.
  • Lead the implementation and development of product risk management tools.
  • Demonstrate good working knowledge and application of validation and statistical techniques to comply with regulatory requirements and internal standards.
  • Promote a culture of quality-centric patient care and customer satisfaction within the New Product Development team.
  • Ensure compliance to BSC's quality, business, and health & safety systems and market/legal regulations.
  • Provide quality input as required at defined project/product/process milestones.
Requirements
  • Bachelor's Degree in Engineering (Electrical Engineering and/or Systems Engineering highly preferred).
  • 5+ years of relevant work experience.
  • Knowledge of ISO 13485, ISO 14971, IEC 62366-1.
  • Experience with design controls, design inputs and outputs, and risk mitigation activities.
  • Experience with systems and electrical/software design and test experience with IEC 60601-1 and collateral standards.
  • Excellent analytical and communication skills (written and oral).
  • Excellent organization and time management skills.
  • Interest in biomedical or health-related industry.
Preferred Qualifications
  • 2+ years of experience in a Design Assurance role.
  • 5+ years of experience in the medical device industry.


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