Senior Design Quality Engineer — Medical Devices (Hybrid)

Boston Scientific; Waltham (MA); Hybrid; USD 89,000 - 170,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Boston Scientific seeks a Senior Design Quality Engineer to lead design assurance for a critical medical device in the Electrophysiology space. You will drive system, software, and hardware quality across the product lifecycle and mentor junior engineers while partnering with R&D, regulatory, manufacturing and clinical teams.

The role is hybrid and based in Waltham, MA or Arden Hills, MN with on-site three days per week; Montreal, Canada is also considered. Relocation assistance may be available.

Qualifications

• Design controls, risk management standards knowledge (ISO 14971, 21 CFR 820, ISO 13485).
• Experience leading software and system QA in medical devices.
• Experience maintaining FMEAs and Hazard Analyses for hardware/software/system.
• Strong problem-solving and CAPA leadership.
• Excellent communicator; able to influence stakeholders.

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 the Capital Equipment, including Design & Development planning, risk management, design verification, and validation.
• Collaborate with R&D, regulatory, manufacturing, clinical teams on design and compliance throughout lifecycle.
• Own and maintain risk management files (Hazard Analysis, FMEAs) across hardware, software, system risks.
• Lead root cause investigations and CAPAs with minimal oversight.
• Provide mentorship to junior engineers on design assurance and regulatory requirements.
• Identify gaps and opportunities for continuous improvement in processes, tools, documentation.
• Act as primary contact for design assurance during audits and inspections.
• Manage multiple priorities and influence project teams toward quality-centric decisions.

Skills

Quality Assurance

Design Controls

Risk Management

FMA

Hazard Analysis

CAPA Investigations

Root Cause Analysis

Software Quality

Cross-functional Leadership

Agile

Communication

Education

Bachelor's degree in Mechanical, Electrical, Software, Biomedical Engineering

Job description

Boston Scientific seeks a Senior Design Quality Engineer to lead design assurance for a critical medical device in the Electrophysiology space. You will drive system, software, and hardware quality across the product lifecycle and mentor junior engineers while partnering with R&D, regulatory, manufacturing and clinical teams.

The role is hybrid and based in Waltham, MA or Arden Hills, MN with on-site three days per week; Montreal, Canada is also considered. Relocation assistance may be available.