Staff Design Quality Engineer

Butterfly Network•Burlington, MA

2d•$145,000 - $160,000•Hybrid

About The Position

The Staff Design Quality Engineer is responsible for supporting new hardware and software medical device product development, sustaining product line activities, and hardware customer quality activities. This individual will serve as the Design Quality Project Lead for cross-functional teams. The position reports to [Senior Manager, Quality Engineering]. On a daily basis, the Staff Design Quality Engineer will interact with R&D, Program Management, Manufacturing Operations and Engineering, Quality Management Systems, Regulatory, Clinical, Marketing, customer-facing teams, and, as appropriate, customers. The primary objective is to drive quality into product design and to support customer issue resolution. The role will 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. The Staff Design Quality Engineer will communicate quality metrics to promote continual improvement and compliance with Butterfly Network's QMS procedures, applicable laws, regulations, standards, and guidance. This position contributes to the development, establishment, and maintenance of design controls, quality engineering methodologies, systems, and practices that satisfy both Butterfly Network's internal requirements and regulatory agency requirements.

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.
Excellent proficiency with 8D problem-solving tools and methods, including root cause analysis, containment, corrective actions, preventive actions, and effectiveness checks.
Ability to quickly understand technical details related to customer complaints, quality issues, hardware failures, manufacturing escapes, and product risk.
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 for regulated medical devices.
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.
Ability to design, iterate, and optimize complex prompts that extract precise, high-utility outputs from AI models for sophisticated workflows.

Nice To Haves

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, customer communications, 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, supplier audits, or other regulatory 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.

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.
Own or maintain medical device risk management files in accordance with ISO 14971.
Utilize 8D problem-solving tools and methods, including root cause analysis, containment, corrective actions, preventive actions, and effectiveness checks.
Quickly understand technical details related to customer complaints, quality issues, hardware failures, manufacturing escapes, and product risk.
Communicate quality metrics to promote continual improvement and compliance with Butterfly Network's QMS procedures, applicable laws, regulations, standards, and guidance.
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.
Contribute to the development, establishment, and maintenance of design controls, quality engineering methodologies, systems, and practices that satisfy both Butterfly Network's internal requirements and regulatory agency requirements.
Design, iterate, and optimize complex prompts that extract precise, high-utility outputs from AI models for sophisticated workflows.