Staff Design Quality Engineer - MedTech & AI/ML

Butterfly Network, Inc.; New York (NY); Hybrid; USD 145,000 - 160,000; Full time

Benefits offered by this job

Health insurance

401k match

ESPP

Unlimited PTO

Parental Leave

Equity

Job summary

Butterfly Network, Inc. is seeking a Staff Design Quality Engineer to drive design quality for hardware and software medical devices. You will lead cross‑functional teams, implement design controls, and support risk management and regulatory compliance.

The role interfaces with R&D, Manufacturing, Regulatory, and Quality teams to ensure high quality outcomes. Hybrid work in NYC, Burlington MA, or SF Bay Area with in‑office days.

Qualifications

• Experience with design quality engineering in regulated medical/device environments.
• Knowledge of ISO 14971 risk management and IEC 60601 electrical safety is preferred.
• Familiarity with AI/ML in SaMD and regulatory documentation.
• Ability to lead audits and manage quality documentation across teams.

Responsibilities

• Lead design quality activities across hardware and software medical device projects.
• Coordinate cross‑functional teams to ensure design controls and risk management.
• Prepare quality updates for executives and customers; drive continuous improvement.
• Support regulatory inspections, notified body audits, and supplier audits.
• Maintain and improve QMS processes and design control documentation.

Skills

8D problem-solving

Cross-functional leadership

Regulatory awareness

Quality root cause analysis

Technical communication

Education

Bachelor's degree in engineering or related field

Tools

eQMS

PLM

Requirements management

Job description

Butterfly Network, Inc. is seeking a Staff Design Quality Engineer to drive design quality for hardware and software medical devices. You will lead cross‑functional teams, implement design controls, and support risk management and regulatory compliance.

The role interfaces with R&D, Manufacturing, Regulatory, and Quality teams to ensure high quality outcomes. Hybrid work in NYC, Burlington MA, or SF Bay Area with in‑office days.