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Boston Scientific Design Assurance Engineer III - Electrophysiology 
Canada, Ontario, Mississauga 
792292318

26.07.2024

Canada-ON-Mississauga; Canada-ON-Toronto


Your responsibilities will include:

  • Responsible for design control and risk management of next-generation capital equipment devices.
  • Uses clinical knowledge/Data to influence how devices they are working on are tested and designed.
  • Responsible for the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
  • Builds quality into all aspects of work by maintaining compliance to all quality requirements.
  • Plans, organizes and prioritizes own daily work routine to meet established schedule.
  • Utilize standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
  • Apply technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Other duties as required.

Required qualifications:

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

Preferred qualifications:

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