Senior Design Quality Engineer - Electrophysiology (Hybrid)

Boston Scientific; Arden; Hybrid; CAD 113,000 - 224,000; Full time

Job summary

Boston Scientific, Canada, seeks a Senior Design Quality Engineer to lead design assurance for a critical electrophysiology medical device. You will drive risk management, design controls, and cross-functional collaboration to ensure safety and regulatory compliance.

The hybrid role prefers Montreal-based work with on-site presence three days per week; relocation assistance may be available. You will mentor junior engineers and influence robust design decisions across the product lifecycle.

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.
• Expertise in Design Controls, Risk Management (ISO 14971), Quality System Regulations (21 CFR 820), and ISO 13485.
• Proven ability to independently lead complex product development projects including software and system QA activities.
• 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, able to influence stakeholders and lead cross-functional initiatives.
• Thrives in fast-paced environments and can navigate ambiguity with sound judgment.

Responsibilities

• Serve as the technical authority within Quality for system integration, design decisions, risk management, and software development & validation.
• Independently lead design control activities for Capital Equipment, including planning, risk management, verification, and validation with a focus on robustness.
• Collaborate with R&D, regulatory, manufacturing, and clinical teams on design and compliance across the product lifecycle.
• Own and maintain risk management files (FMEAs, Hazard Analyses) for hardware, software, and system risks.
• Lead root cause investigations and CAPA, NCEPs, and complaints to drive corrective actions.
• Ensure post-market experience informs risk management and design controls.
• Mentor junior engineers on design assurance, regulatory requirements, and quality processes.
• Identify gaps for continuous improvement in processes, tools, and documentation.
• Act as primary contact for audits and regulatory inspections.

Skills

Quality Assurance

Design Assurance

Design Controls

Risk Management

Software Quality

Root Cause Analysis

CAPA Investigations

Cross-functional Collaboration

Education

Bachelor’s degree in Mechanical, Electrical, Software, Biomedical Engineering or related field

Tools

FMEA

Hazard Analysis

IEC 62304

Job description

Boston Scientific, Canada, seeks a Senior Design Quality Engineer to lead design assurance for a critical electrophysiology medical device. You will drive risk management, design controls, and cross-functional collaboration to ensure safety and regulatory compliance.

The hybrid role prefers Montreal-based work with on-site presence three days per week; relocation assistance may be available. You will mentor junior engineers and influence robust design decisions across the product lifecycle.