Senior Design Quality Engineer - Electrophysiology Systems

Boston Scientific; Arden Hills (MN, CA); Hybrid; USD 80,000 - 158,000; Full time

Job summary

Boston Scientific is seeking a Senior Design Quality Engineer for the Electrophysiology space. The role leads design assurance across hardware, software, and system domains, ensuring product safety and regulatory compliance.

Based in a hybrid setup, Montreal preferred, with on-site presence at least 3 days/week. Candidates in Marlborough, MA; Waltham, MA; or Arden Hills, MN may also be considered, relocation assistance may be available.

Qualifications

• Bachelor’s degree in engineering or related technical discipline.
• 6+ years of experience in Quality Assurance, Design Assurance, Software Quality, or related roles in medical device industry.
• Experience with Design Controls, ISO 14971, 21 CFR 820, and ISO 13485.
• Proven ability to independently lead complex product development projects including software and system QA activities.
• Experience maintaining risk documentation such as FMEAs and Hazard Analyses.
• Strong problem-solving with CAPA investigations and root cause analysis.
• Excellent communication, able to influence stakeholders and lead cross-functional initiatives.
• Thrives in fast-paced environments with ambiguity and good judgment.

Responsibilities

• Serve as the technical authority within Quality for system integration, design decisions, risk management, and software development & validation.
• Lead design control activities for Capital Equipment, including planning, risk management, verification, and validation.
• Collaborate with R&D, regulatory, manufacturing and clinical teams on design and compliance throughout the product lifecycle.
• Own and maintain risk management files (Hazard Analysis, FMEAs) covering hardware, software and system risks.
• Lead root cause investigations and CAPA/NCEP/complaints with corrective actions.
• Incorporate post-market experience into risk management and design controls.
• Mentor junior engineers on design assurance and regulatory requirements.
• Identify gaps and drive continuous improvement in processes and documentation.
• Act as primary contact for audits and regulatory inspections.
• Manage multiple priorities and influence teams toward quality-centric decisions.

Skills

Quality Assurance

Design Assurance

Risk Management

CAPA investigations

Root cause analysis

Regulatory knowledge

Cross-functional collaboration

Mentoring juniors

Leadership

Audits

Education

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

Tools

IEC 62304

Design Controls tools

Risk management tools (FMEA)

Job description

Boston Scientific is seeking a Senior Design Quality Engineer for the Electrophysiology space. The role leads design assurance across hardware, software, and system domains, ensuring product safety and regulatory compliance.

Based in a hybrid setup, Montreal preferred, with on-site presence at least 3 days/week. Candidates in Marlborough, MA; Waltham, MA; or Arden Hills, MN may also be considered, relocation assistance may be available.