Electrophysiology Design Quality Lead

Boston Scientific; Waltham (MA); Hybrid; USD 80,000 - 158,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Boston Scientific is seeking a Senior Design Quality Engineer to lead design assurance for a critical medical device in electrophysiology. This hybrid role, based preferably in Montreal, requires on-site presence three days a week and may consider Marlborough, Waltham MA, or Arden Hills, MN candidates.

Responsibilities include acting as Quality authority across hardware, software and system domains, managing risk files, leading CAPAs, and mentoring junior engineers to ensure product safety and

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Software, Biomedical Engineering or related technical field.
• 6+ years in Quality Assurance, Design Assurance, Software Quality, or related medical device roles.
• Expertise in Design Controls, ISO 14971, 21 CFR 820, and ISO 13485.
• Ability to lead product development projects including software and system QA.
• Experience with FMEAs and Hazard Analyses (hardware/software/system focus).
• Strong problem-solving and CAPA leadership abilities.
• Excellent communication, capable of cross-functional influence.
• thrives in a fast-paced, ambiguous environment.

Responsibilities

• Act as technical authority for Quality in system integration, design decisions, risk mgmt, and software validation.
• Lead design control activities for Capital Equipment incl. planning, risk mgmt, verification & validation.
• Collaborate with R&D, regulatory, manufacturing, and clinical teams on design and compliance.
• Own risk management files (FMEAs, Hazard Analysis) for hardware, software, and systems.
• Lead root cause investigations and CAPA, NCEPs, and complaints with corrective actions.
• Ensure post-market experience informs risk management and design controls.
• Mentor junior engineers on design assurance and regulatory requirements.
• Identify gaps and opportunities for process improvement in development.
• Serve as primary QA contact during audits and regulatory inspections.
• Manage multiple priorities and influence project teams toward quality decisions.

Skills

Design Controls

Risk Management

Quality Systems

FMEA

CAPA Investigations

Root Cause Analysis

Cross-functional Leadership

Regulatory Knowledge

Software Quality

Communication Skills

Education

B.S. in Engineering

Job description

Boston Scientific is seeking a Senior Design Quality Engineer to lead design assurance for a critical medical device in electrophysiology. This hybrid role, based preferably in Montreal, requires on-site presence three days a week and may consider Marlborough, Waltham MA, or Arden Hills, MN candidates.

Responsibilities include acting as Quality authority across hardware, software and system domains, managing risk files, leading CAPAs, and mentoring junior engineers to ensure product safety and