Boston Scientific Senior Design Assurance Engineer - Electrophysiology 

Canada, Ontario, Mississauga 

111396977

Canada-ON-Mississauga; Canada-ON-Toronto

Your responsibilities will include:

• Responsible for design control and risk management of novel electrophysiology devices.
• Uses clinical knowledge to influence how devices they are working on are tested and designed
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Independently, or as a member of a team, develops, directs, and executes plans for design control and risk management of complex projects
• Leads the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
• Demonstrates good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards
• Adds to and promotes the culture of quality-centric patient care and customer satisfaction within the New Product Development team
• Promotes and influences compliance to BSC’s quality, business and health & safety systems and market/legal regulations
• Provides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines). Comply with the Health & Safety policies of the company and inform management of unsafe working conditions.
• Other duties as required.

Required qualifications:

• 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