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
- Robust communication, investigation, and stakeholder influence skills

Apply design controls, risk management, and system quality expertise to advance electrophysiology device assurance at Boston Scientific.

📌 Senior Design Assurance Engineer Electrophysiology (Montreal)
🏢 Boston Scientific
📍 Montreal