Boston Scientific Design Assurance Engineer III - Electrophysiology 

Canada, Ontario, Mississauga 

792292318

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