Design Assurance Engineer III

2 months ago


Mississauga, Ontario, Canada Boston Scientific Full time

About the Role

We are seeking a highly skilled Design Assurance Engineer III to join our Design Assurance team at Boston Scientific. This position plays a critical role in ensuring the quality and safety of our medical devices.

Key Responsibilities

  • Develop and implement design control and risk management strategies for next-generation capital equipment devices.
  • Utilize clinical knowledge and data to inform device testing and design.
  • Implement and develop product risk management tools, such as Hazard Analysis, Fault Tree, and FMEAs.
  • Maintain compliance with quality requirements and ensure that quality is built into all aspects of work.
  • Plan, organize, and prioritize daily work to meet established schedules.
  • Apply technical skills, including statistical analysis and problem-solving techniques, to determine product acceptance and evaluate process capabilities.
  • Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.

Requirements

  • Bachelor's Degree in Engineering (Electrical, Biomedical preferred)
  • 3+ years of related working experience from the Medical Device Industry
  • Knowledge of ISO 13485, ISO 14971, IEC 62366-1, and IEC 62304
  • Demonstrated interpersonal skills with the ability to work within a team environment
  • Strong written and verbal communication skills
  • Ability to work independently under limited supervision

Preferred Qualifications

  • Six Sigma problem-solving methodologies
  • Training experience in FDA regulations or ISO standards


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