Senior Design Quality Engineer in Montréal

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:

We have a high-impact opportunity for a Senior Design Quality Engineer to lead design assurance efforts for a critical medical device in the Electrophysiology space. This role requires a self-driven professional capable of independently managing complex technical challenges and driving to solutions across hardware, software, and system domains. The Senior Engineer will influence strategic quality initiatives, mentor junior engineers, and serve as a key resource in cross-functional teams to ensure product safety, regulatory compliance, and design robustness.

Work mode:

This hybrid role is preferably based in Montreal, Canada, with on-site presence required at least three (3) days per week. Candidates based in Marlborough, or Waltham MA or Arden Hills, MN may also be considered. Relocation assistance may be available for this position at this time.

Your responsibilities will include:

• Serve as the technical authority within Quality for system integration, design decisions, risk management, and software development & validation.
• Independently lead design control activities for the Capital Equipment, including Design & Development planning, risk management, design verification, and validation efforts, with a strong focus on robustness of system design and documentation.
• Collaborate closely with R&D, regulatory, manufacturing, and clinical teams to provide expert guidance on design and compliance matters throughout the product lifecycle.
• Own and maintain comprehensive risk management files (Hazard Analysis, FMEAs), ensuring robust coverage of both hardware, software, and system risks, applying advanced risk mitigation strategies to influence robust design decisions.
• Lead root cause investigations and resolution of test failures, CAPAs, NCEPs, and complaints, driving corrective actions and preventive measures with minimal oversight.
• Ensure post-market experience is effectively incorporated into risk management and design controls through assessment of observed versus anticipated failure modes, harms, severity, occurrence, and effectiveness of existing risk controls.
• Provide mentorship and guidance to junior engineers on design assurance best practices, regulatory requirements, and quality processes.
• Proactively identify gaps and opportunities for continuous improvement in product development processes, tools, and documentation.
• Act as a primary point of contact for design assurance during internal and external audits and regulatory inspections.
• Effectively manage multiple priorities and projects independently, demonstrating strong decision-making skills in ambiguous situations, and ability to influence project team towards quality-centric decisions and behaviors.

What we’re looking for:

Required Qualifications:

• Bachelor’s degree in Mechanical, Electrical, Software Engineering, Biomedical Engineering, or related technical discipline.
• 6+ years of experience in Quality Assurance, Design Assurance, Software Quality, or related roles in the medical device industry.
• Demonstrated expertise in Design Controls, Risk Management (ISO 14971), Quality System Regulations (21 CFR 820), and Quality management systems (ISO 13485).
• Proven ability to independently lead complex product development projects, including software and system quality assurance activities, from inception through completion.
• Experience developing and maintaining risk documentation such as FMEAs and Hazard Analyses with hardware, software and system focus.
• Strong problem-solving skills with experience leading root cause analysis and CAPA investigations.
• Excellent communication skills, capable of influencing stakeholders at all levels and leading cross-functional initiatives.
• Ability to thrive in a fast-paced environment and navigate ambiguity with sound judgment.

Preferred Qualifications:

• Experience mentoring or leading junior engineers in design assurance or software/systems engineering activities.
• Experience with Capital Equipment.
• Knowledge of software quality standards (IEC 62304) and software/system development principles.
• Prior experience working on or supporting cardiac mapping systems or similar complex medical device platforms.
• Strong project management skills and familiarity with agile development methodologies.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.