Staff Design Quality Engineer

Butterfly Network, Inc. (NYSE: BFLY) is driving a digital revolution in ultrasound imaging and sensing with its proprietary Ultrasound-on-Chip™ semiconductor technology and software solutions. The company combines advanced hardware with cloud software and AI, enterprise workflow solutions, and third-party development platforms to enable affordable, accessible ultrasound across medical and non-medical markets.

About the role

The Staff Design Quality Engineer supports new hardware and software medical device product development, sustaining product line activities, and hardware customer quality activities. This individual serves as the Design Quality Project Lead for cross-functional teams, driving quality into product design and supporting customer issue resolution. The role advises on design controls, cybersecurity, AI/ML-enabled medical device considerations, risk management, human factors, usability engineering, verification, and validation.

Responsibilities

• Support regulatory audits, notified body audits, FDA inspections, internal audits, customer audits, and supplier or contract manufacturer audits related to design controls, risk management, AI/ML documentation, usability engineering, cybersecurity, electrical safety, hardware quality, and product quality.
• Serve as the Design Quality Project Lead for cross-functional teams, interacting with R&D, Program Management, Manufacturing Operations, Quality Management Systems, Regulatory, Clinical, Marketing, and customer-facing teams.
• Advise cross-functional 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 Butterfly Network's QMS procedures, applicable laws, regulations, standards, and guidance.
• Contribute to the development, establishment, and maintenance of design controls, quality engineering methodologies, systems, and practices that satisfy internal and regulatory requirements.
• Apply 8D problem-solving tools and methods, including root cause analysis, containment, corrective actions, preventive actions, and effectiveness checks for customer complaints and quality issues.
• Understand technical details related to customer complaints, hardware failures, manufacturing escapes, and product risk.

Requirements

• 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 within the medical device, semiconductor, electronics, or other 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, including user needs, design inputs, design outputs, design verification, design validation, design reviews, design transfer, and design changes.
• Experience owning or maintaining medical device risk management files in accordance with ISO 14971.
• Proficiency with 8D problem-solving tools and methods.
• Knowledge of AI/ML development and validation considerations, including data quality, training and test datasets, model performance, model monitoring, bias, generalizability, algorithm change management, and documentation expectations.
• Knowledge of human factors and usability engineering principles for medical devices, including use-related risk analysis, formative evaluations, summative validation, and IEC 62366.
• Experience with SMT, PCBA, semiconductor manufacturing practices, PCBA controls, electronics manufacturing, supplier manufacturing controls, or contract manufacturer quality.
• Familiarity with cybersecurity expectations for connected medical devices, including cybersecurity risk assessment, threat modeling, vulnerability assessment, security requirements, and cybersecurity verification.
• Familiarity with IEC 60601 electrical safety testing requirements and ability to review electrical safety test plans, reports, deviations, and related design or risk impacts.
• Familiarity with quality management system requirements, including FDA 21 CFR Part 820 and ISO 13485.
• Strong written and oral communication skills, with the ability to prepare executive-ready and customer-facing quality updates.
• Strong cross-functional leadership skills, including experience coordinating teams across engineering, manufacturing, quality, regulatory, software, hardware, suppliers, and contract manufacturers.

Preferred Qualifications

• Experience with Class II or Class III medical devices.
• Experience with AI/ML-enabled SaMD, imaging systems, diagnostic platforms, robotic systems, remote patient monitoring, wearables, connected devices, or clinical decision support products.
• Experience in hardware customer quality, semiconductor quality, electronics quality, or chip-side quality, including customer-facing issue resolution, quality metrics, and structured complaint response.
• Experience with semiconductor manufacturing processes, including silicon fabrication, package assembly, final test, component-level reliability, board-level reliability, or system-level reliability.
• Experience with server system hardware, embedded systems, connected hardware, electrical systems, hardware/software integration, or system-level hardware testing.
• Working knowledge of IEC 62304, IEC 62366, AAMI TIR57, AAMI TIR97, EU MDR, AI/ML guidance, cybersecurity guidance, or other applicable medical device standards and guidance.
• Experience supporting regulatory submissions, notified body audits, inspections, customer audits, or supplier audits for AI/ML-enabled, software-enabled, hardware-enabled, or connected medical devices.
• Experience using eQMS, PLM, requirements management software, document control systems, model lifecycle management tools, data analytics tools, or risk management tools.
• Experience leading or supporting CAPA, nonconformance investigations, complaint investigations, post-market surveillance activities, field actions, customer escalations, or recovery plans.
• ASQ certification, Six Sigma certification, RAC certification, or other relevant quality/regulatory certification.

Benefits

• Comprehensive health insurance, including dental and vision coverage, with annual HSA contributions.
• Employee Assistance Program for emotional health and day-to-day needs.
• 401k plan with company match and Employee Stock Purchase Plan (ESPP).
• Unlimited Paid Time Off plus 10 holiday days per year.
• Parental Leave with additional support for primary caregivers.
• Competitive salaried compensation and equity.

Pay

Estimated salary for this role is $145,000 + bonus + equity + benefits in NYC or Burlington, MA, and $160,000 + bonus + equity + benefits in San Francisco. Actual pay is determined by skills, qualifications, experience, and market demand.

Schedule

This hybrid role requires two to three days per week in the office, based out of one of our NYC, Burlington MA, or SF Bay Area offices.

Candidates must be authorized to work in the United States without immigration sponsorship.