Senior Design Assurance Engineer

3 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. This position plays a critical role in ensuring the adequacy of design controls and subsequent production and process controls for novel electrophysiology devices.

Key Responsibilities
  • Develop and execute plans for design control and risk management of complex projects
  • Lead the implementation and development of product risk management tools, such as Hazard Analysis, Fault Tree, and FMEAs
  • Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
  • Collaborate with new product development and product life cycle teams to ensure design controls are met
  • Develop and maintain good working knowledge and application of validation and statistical techniques to comply with regulatory requirements and internal standards
  • Contribute to the culture of quality-centric patient care and customer satisfaction within the New Product Development team
  • Ensure compliance to Boston Scientific's quality, business, and health & safety systems and market/legal regulations
Requirements
  • Bachelor's Degree in Engineering (Mechanical, Biomedical preferred)
  • 5+ years related working experience in the medical device industry
  • Knowledge of ISO 13485, ISO 14971, IEC 62366-1
  • Experience with design controls, design inputs and outputs, and risk mitigation activities
  • 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 directly in a Design Assurance role


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