Senior Design Assurance Engineer

3 days 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 at Boston Scientific. This position plays a critical role in ensuring the quality and safety of our medical devices, working closely with new product development and product life cycle teams.

Key Responsibilities

  • Develop and implement design control and risk management strategies for novel electrophysiology devices.
  • Collaborate with cross-functional teams to identify and mitigate quality risks.
  • Apply sound problem-solving methodologies to resolve quality issues and improve product design.
  • Lead the development and execution of plans for design control and risk management of complex projects.
  • Implement and develop product risk management tools, such as Hazard Analysis and Fault Tree analysis.
  • Ensure compliance with regulatory requirements and internal standards through the application of validation and statistical techniques.
  • Promote a culture of quality-centric patient care and customer satisfaction within the New Product Development team.
  • Provide quality input and expertise as required, at defined project/product/process milestones.

Requirements

  • Bachelor's Degree in Engineering (Mechanical or Biomedical preferred).
  • 5+ years of related working experience in the medical device industry.
  • Knowledge of ISO 13485, ISO 14971, and IEC standards.
  • Experience with design controls, design inputs and outputs, and risk mitigation activities.
  • Excellent analytical and communication skills.
  • Excellent organization and time management skills.

Preferred Qualifications

  • 2+ years of experience directly in a Design Assurance role.

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 are dedicated to advancing science for life. Our mission is to transform lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.



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