Senior Design Assurance Engineer Electrophysiology

Location: Montreal

Lead design assurance for electrophysiology medical devices using risk management and system quality expertise in hybrid Montreal work. Influence safety, compliance, and robust design across complex products.
Boston Scientific seeks a Senior Design Quality Engineer to manage technical challenges across hardware, software, and system domains. You will lead design controls, support product lifecycle decisions, and influence strategic quality initiatives. The position requires expertise in medical device quality systems, risk documentation, and software validation.

Key Responsibilities:

Lead design planning, risk management, verification, and validation activities
Serve as Quality’s technical authority for system integration decisions
Maintain hardware, software, and system risk management files
Investigate test failures, CAPAs, NCEPs, and complaints
Guide audits, inspections, and junior engineer development
Requirements:
Bachelor’s degree in engineering or related technical discipline
Six-plus years in medical device quality or design assurance
Expertise in ISO 14971, 21 CFR 820, and ISO 13485
Experience leading complex software and system quality activities
Strong communication, investigation, and stakeholder influence skills
Apply design controls, risk management, and system quality expertise to advance electrophysiology device assurance at Boston Scientific.