Staff Design Quality Engineer

Butterfly Network, Inc.

Staff Design Quality Engineer advancing Butterfly Network’s portable ultrasound and AI-enabled medical devices. Leading design quality, risk management, audits, and customer issue resolution across cross-functional teams.

Posted 8/4/2026full-timeBurlington • California, Massachusetts, New York • 🇺🇸 United StatesLead💰 $145,000 - $160,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in design quality engineering and risk management for medical devices, with a strong focus on AI/ML-enabled products and compliance with regulatory standards. Proficient in cross-functional collaboration and quality improvement methodologies to ensure product excellence.

Highest-signal resume keywords

Design Quality EngineeringMedical Device Risk ManagementAI/ML-Enabled Medical DevicesQuality Management Systems ComplianceCross-Functional Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Design ControlsQuality Engineering Methodologies8D Problem-Solving ToolsHuman Factors EngineeringUsability EngineeringISO 14971 ComplianceIEC 62366 KnowledgeFDA 21 CFR Part 820 FamiliarityISO 13485 FamiliarityAI Model Optimization

Soft Skills

Strong Written CommunicationStrong Oral CommunicationCross-Functional Coordination

Tools & Technologies

EQMSPLMCAPAComplaint Investigation ToolsCybersecurity Standards

Certifications & Qualifications

ASQ CertificationSix Sigma CertificationRAC Certification

Industry Keywords

Medical Device DevelopmentRegulated Industry ExperienceClinical Decision Support ToolsDiagnostic AlgorithmsPredictive ModelsElectronics ManufacturingSupplier Manufacturing ControlsConnected Medical DevicesElectrical Safety TestingContract Manufacturer Quality

Tech Stack

Tools & technologies

Cyber Security

About the role

Key responsibilities & impact

Support new hardware and software medical device product development
Support sustaining product line activities and hardware customer quality activities
Serve as Design Quality Project Lead for cross-functional teams
Advise teams on design controls, cybersecurity, AI/ML-enabled medical device considerations, risk management, human factors and usability engineering, verification and validation, and mitigations
Communicate quality metrics to promote continual improvement and compliance with QMS procedures, laws, regulations, standards, and guidance
Develop, establish, and maintain design controls, quality engineering methodologies, systems, and practices
Interact with R&D, Program Management, Manufacturing Operations and Engineering, Quality Management Systems, Regulatory, Clinical, Marketing, customer-facing teams, and customers as appropriate
Support regulatory, notified body, FDA, internal, customer, supplier, and contract manufacturer audits
Support customer issue resolution and cross-functional product quality activities

Requirements

What you’ll need

Bachelor’s degree in engineering, life sciences, biomedical engineering, mechanical engineering, electrical engineering, software engineering, quality, or a related technical field
Experience in design quality engineering, quality engineering, product development, systems engineering, software quality, AI/ML quality, hardware quality, or a related role in a regulated industry
Experience with AI/ML-enabled medical devices, software-enabled medical devices, SaMD, clinical decision support tools, diagnostic algorithms, imaging algorithms, predictive models, or other regulated AI/ML product development
Strong working knowledge of medical device design controls
Experience owning or maintaining medical device risk management files in accordance with ISO 14971
Strong proficiency with 8D problem-solving tools and methods
Ability to understand technical details related to customer complaints, quality issues, hardware failures, manufacturing escapes, and product risk
Knowledge of AI/ML development and validation considerations
Knowledge of human factors and usability engineering principles, including IEC 62366
Experience with SMT, PCBA, semiconductor manufacturing, electronics manufacturing, supplier manufacturing controls, or contract manufacturer quality
Familiarity with cybersecurity expectations for connected medical devices
Familiarity with IEC 60601 electrical safety testing requirements
Familiarity with FDA 21 CFR Part 820 and ISO 13485
Strong written and oral communication skills
Strong cross-functional leadership and coordination skills
Ability to design, iterate, and optimize complex prompts for AI models
Candidates must be authorized to work in the United States; no immigration sponsorship is provided
Preferred/ideal qualifications include Class II or Class III medical device experience, additional standards knowledge, eQMS/PLM experience, CAPA and complaint investigation experience, and ASQ, Six Sigma, or RAC certification

Benefits

Comp & perks

Comprehensive health insurance, including dental and vision coverage
Annual Health Savings Account (HSA) contributions for enrolled employees
Employee Assistance Program
401k plan and match
Employee Stock Purchase Plan (ESPP) for eligible employees
Unlimited Paid Time Off
10 holiday days per year
Parental leave and additional support for primary caregivers
Competitive salaried compensation
Equity
Opportunity to build a healthcare product