Staff Design Quality Engineer

Company Description 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. Butterfly first proved its technology in the point-of-care ultrasound market – commercializing the world’s first single-probe, whole-body portable ultrasound device, which is now on its best-selling, third-generation: Butterfly iQ3™. The Company combines its advanced hardware with cloud software and AI, an enterprise workflow solution (Compass AI™) and other offerings to drive adoption of affordable, accessible ultrasound. Butterfly also enables third-party development of imaging AI apps through Butterfly Garden™, its software development kit and AI partnership initiative.

In addition to its medical imaging products, Butterfly Embedded™ is the Company’s Ultrasound-on-Chip™ licensing and co-development program designed to enable a new wave of ultrasound-enabled technologies across non-competitive healthcare markets and beyond. Through Butterfly Embedded™, partners can build and scale novel ultrasound applications powered by Butterfly’s proprietary semiconductor chip and software platform. Butterfly’s innovations have been recognized by Prix Galien USA, Fierce 50, TIME’s Best Inventions and Fast Company’s World Changing Ideas, among other achievements.

We’re a team of bold thinkers, problem-solvers, and innovators ready to shape the future of medical imaging. Let’s build something extraordinary together!

Job Description 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.

Qualifications Baseline skills/experiences/attributes:

• 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.
• 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, …