Senior Design Assurance Engineer Electrophysiology

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 activitiesServe as Quality’s technical authority for system integration decisionsMaintain hardware, software, and system risk management filesInvestigate test failures, CAPAs, NCEPs, and complaintsGuide audits, inspections, and junior engineer developmentRequirements:
Bachelor’s degree in engineering or related technical disciplineSix-plus years in medical device quality or design assuranceExpertise in ISO 14971, 21 CFR 820, and ISO 13485Experience leading complex software and system quality activitiesStrong communication, investigation, and stakeholder influence skillsApply design controls, risk management, and system quality expertise to advance electrophysiology device assurance at Boston Scientific.
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