Lead Design Quality Engineer – Medical Devices & AI/ML

Socket.dev; Burlington (MA); Hybrid; USD 145,000 - 160,000; Full time

Benefits offered by this job

Health insurance

401k plan + match

ESP P

Unlimited PTO

Parental Leave

Equity

Hybrid work model

Job summary

Butterfly Network, a US-based medical imaging company, seeks a Staff Design Quality Engineer to support hardware and software development, sustaining activities, and cross-functional quality leadership. The role emphasizes design controls, cybersecurity, AI/ML considerations, risk management, usability, and validation under QMS requirements.

You will engage R&D, regulatory, manufacturing, and quality teams to ensure compliant, high-quality medical devices while driving continual improvement and

Qualifications

• Experience in design quality engineering in medical devices or regulated industry.
• Familiarity with FDA 21 CFR 820, ISO 13485 and IEC standards.
• Ability to lead cross-functional quality initiatives and audits.
• Knowledge of AI/ML development and validation considerations.

Responsibilities

• Drive quality into product design and design controls across teams.
• Advise on cybersecurity, AI/ML considerations, risk management and usability.
• Support regulatory submissions and align with QMS procedures.
• Prepare executive-ready quality updates and metrics for stakeholders.

Skills

Design quality

Regulatory audits

AI/ML quality

Risk management

Cybersecurity

IEC 60601

Project leadership

Education

Bachelor’s degree in engineering or related field

Tools

eQMS

PLM

Requirements mgmt

Job description

Butterfly Network, a US-based medical imaging company, seeks a Staff Design Quality Engineer to support hardware and software development, sustaining activities, and cross-functional quality leadership. The role emphasizes design controls, cybersecurity, AI/ML considerations, risk management, usability, and validation under QMS requirements.

You will engage R&D, regulatory, manufacturing, and quality teams to ensure compliant, high-quality medical devices while driving continual improvement and