Senior Design Quality Engineer

About the role

Boston Scientific is seeking a senior design quality professional to lead design assurance for a critical electrophysiology medical device. The role is based in Montreal and operates in a hybrid model, requiring on‑site presence three days a week. You will work across hardware, software and system domains to ensure product safety, regulatory compliance and robust design.

Key responsibilities

• Act as the technical authority for quality in system integration, design decisions, risk management and software validation.
• Lead design control activities for capital equipment, including planning, risk management, design verification and validation.
• Collaborate with R&D, regulatory, manufacturing and clinical teams to provide guidance throughout the product lifecycle.
• Own and maintain comprehensive risk management files (hazard analysis, FMEAs) and apply advanced mitigation strategies.
• Lead root‑cause investigations, CAPA, NCEP and complaint handling with minimal oversight.
• Mentor junior engineers on design assurance best practices and regulatory requirements.
• Identify gaps and drive continuous improvement in development processes, tools and documentation.
• Serve as primary contact for internal and external audits and regulatory inspections.

Required profile

• Self‑driven senior professional with proven experience in design assurance for medical devices.
• Ability to manage complex technical challenges across hardware, software and system domains.
• Strong decision‑making skills in ambiguous situations and capacity to manage multiple priorities independently.
• Excellent communication and collaboration skills to work with cross‑functional teams.

Required skills

• Design control and verification/validation processes.
• Risk management techniques including hazard analysis and FMEA.
• CAPA and root‑cause analysis methodologies.
• Software development and validation knowledge.
• Regulatory compliance for medical devices.

What we offer

• Hybrid work model with three days on‑site in Montreal.
• Access to latest tools, training and career development resources.
• Opportunity to work on high‑impact electrophysiology technology.