Senior Design Quality Engineer - Electrophysiology

Boston Scientific • Waltham, MA

1d • Hybrid

About The Position

Boston Scientific is seeking a Senior Design Quality Engineer to lead design assurance for a critical medical device in the Electrophysiology space. The role independently manages complex technical challenges across hardware, software, and system domains, influences quality initiatives, mentors junior engineers, and helps ensure product safety, regulatory compliance, and design robustness.

This is a hybrid role, preferably based in Montreal, Canada, with on-site presence required at least three days per week. Candidates based in Marlborough or Waltham, Massachusetts, or Arden Hills, Minnesota, may also be considered. Relocation assistance may be available.

The position serves as a technical authority within Quality and leads design control and risk management activities for Capital Equipment throughout the product lifecycle. It collaborates with cross-functional teams, oversees investigations and corrective actions, incorporates post-market experience into design controls, supports audits and regulatory inspections, and identifies opportunities to improve product development processes. The role requires independent prioritization, sound decision-making in ambiguous situations, and the ability to influence teams toward quality-centric decisions.

Requirements

• Bachelor’s degree in Mechanical, Electrical, Software, or Biomedical Engineering, or a related technical discipline.
• At least 6 years of experience in Quality Assurance, Design Assurance, Software Quality, or related roles in the medical device industry.
• Expertise in Design Controls, Risk Management (ISO 14971), Quality System Regulations (21 CFR 820), and quality management systems (ISO 13485).
• 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 a hardware, software, and system focus.
• Strong problem-solving skills and experience leading root cause analysis and CAPA investigations.
• Excellent communication skills and ability to influence stakeholders at all levels and lead cross-functional initiatives.
• Ability to thrive in a fast-paced environment and navigate ambiguity with sound judgment.

Nice To Haves

• Experience mentoring or leading junior engineers in design assurance or software/systems engineering activities.
• Experience with Capital Equipment.
• Knowledge of software quality standards such as 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.

Responsibilities

• Serve as the technical authority within Quality for system integration, design decisions, risk management, and software development and validation.
• Independently lead design control activities for Capital Equipment, including design and development planning, risk management, design verification, and validation, with a focus on system design robustness and documentation.
• Collaborate with R&D, regulatory, manufacturing, and clinical teams to provide expert guidance on design and compliance throughout the product lifecycle.
• Own and maintain risk management files, including Hazard Analyses and FMEAs, covering hardware, software, and system risks, and apply risk mitigation strategies to influence design decisions.
• Lead root cause investigations and resolution of test failures, CAPAs, NCEPs, and complaints, driving corrective and preventive measures with minimal oversight.
• Incorporate post-market experience into risk management and design controls by assessing observed versus anticipated failure modes, harms, severity, occurrence, and effectiveness of risk controls.
• Mentor and guide junior engineers on design assurance practices, regulatory requirements, and quality processes.
• Identify gaps and opportunities for continuous improvement in product development processes, tools, and documentation.
• Act as a primary design assurance contact during internal and external audits and regulatory inspections.
• Independently manage multiple priorities and projects, make decisions in ambiguous situations, and influence project teams toward quality-centric decisions and behaviors.

Benefits

• Relocation assistance may be available.
• Core and optional employee benefits are offered.
• Exempt, non-sales roles may be eligible for an annual bonus target and long-term incentives, subject to plan eligibility and other requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior