Lead Ultrasound Imaging Engineer (AI & Systems)

Lead Ultrasound Imaging Engineer (AI & Systems) iSono Health is a dynamic and rapidly growing early clinical-commercial stage medical device company dedicated to saving lives and transforming care through innovative robotics, AI, and 3D ultrasound technologies. At iSono Health, we’re pioneering a new era of breast care. We believe every woman deserves access to fast, affordable, and comfortable screenings. That’s why we developed ATUSA, the world’s first AI-powered platform with a point-of-care, automated 3D ultrasound system. To succeed here, you need to think like an entrepreneur, act like a leader, and execute with precision. We value individuals who take initiative, embrace challenges, and are excited to wear multiple hats. Creativity, resilience, and a commitment to excellence are essential as we push the boundaries of what’s possible in healthcare. Our work is exciting because it’s meaningful. Together, we’re empowering women to take control of their health by expanding access to potentially lifesaving ultrasound technology. If you’re passionate about making a difference and ready to be part of a nimble, scrappy team that values impact over hierarchy, iSono Health is the place for you. At iSono Health, success isn’t just about the work—it’s about the mindset. We’re a small but mighty team of dedicated individuals driven by a shared mission: revolutionizing women’s health and making a profound impact for patients and clinicians. With big ambitions and innovative plans, we thrive in a fast‑paced, dynamic environment where every team member owns what they build. Join us in transforming healthcare and be part of a team where every voice matters, every idea counts, and every action contributes to a greater purpose. About the Role The Imaging Engineer at iSono Health will be a highly visible, mission‑critical role that begins as a hands‑on technical contributor and evolves into a team leader and strategic owner of our imaging systems. You will bring expert‑level engineering experience across imaging modalities—particularly diagnostic ultrasound—and play a pivotal role in product development and commercialization. The position drives breakthrough imaging and ultrasound systems to elevate clinicians’ vision, encompassing mechanical, optical, electrical, and algorithmic design elements. We are looking for a hands‑on, ambitious Imaging Engineer who thrives in a fast‑paced environment at the intersection of hardware and software and AI (can learn), someone who can write code, tune beamforming parameters, and ship a real product. This is an excellent role for someone who takes pride in building from the ground up, embraces complexity, and sees leadership as something earned through execution, with real ownership of the existing and future generation of our automated breast ultrasound device. The role is responsible for the smooth and successful transition of product designs to scalable manufacturing, and for ongoing design improvements for launch onward to ensure excellent field performance, high reliability, supply continuity, efficient manufacturing, and product cost optimization. At iSono Health, we’re transforming how and where people access health and diagnose cancer. If you’re passionate about healthcare innovation, motivated to make a global impact, and ready to grow into a leadership role at a venture‑backed startup in Sunnyvale, we’d love to meet you. What You’ll Do Technical Leadership & Execution Take ownership of critical imaging initiatives from concept to execution, driving technical decisions, prototyping rapidly, and guiding system development across mechanical, electrical, and algorithmic domains. Lead hands‑on development of Gen 2 hardware and software upgrades to our ultrasound imaging system. Design, implement, and optimize beamforming algorithms and real‑time signal processing pipelines. Write embedded firmware and imaging software in C#, C++, and Python. Integrate and evaluate Nvidia and other GPU platforms (e.g., Jetson) for edge AI inference and image processing acceleration. Build and maintain automated testing and validation frameworks for imaging performance. Collaborate with AI/ML engineers to develop and deploy machine learning‑based image enhancement solutions. Conduct imaging performance evaluations, support reader studies, and generate technical documentation for regulatory submissions. Work cross‑functionally with hardware, QA, and clinical teams to ensure robust design transfer to manufacturing. Contribute to IP generation and design control documentation aligned with FDA and global medical device standards. Set appropriate priorities for product development by connecting technical focus to key customer needs. Own the planning, execution, and delivery of projects, anticipating risks, resolving challenges, and maintaining alignment with schedule, scope, and budget alongside cross‑functional partners. Be a product sponsor and champion by offering sound technical and business leadership to project teams and actively participating in business and design control review boards. Ensure rigorous design documentation and execution of robust verification and validation processes aligned with customer expectations and quality standards. Deliberately support regulatory submissions by contributing to documentation and ensuring product design aligns with global compliance requirements. Generate and document meaningful IP throughout product development to secure core innovations and long‑term competitiveness. Lead the execution and implementation of advanced, software‑based quantitative ultrasound beamforming techniques, with a strong emphasis on real‑time performance and clinical‑grade image quality. Develop and optimize novel algorithms for image acquisition, processing, and enhancement, including machine learning‑based solutions. Design and lead ultrasound reader studies to evaluate imaging performance; prepare comprehensive reports and documentation for internal stakeholders and regulatory bodies. Stay up to date on emerging technologies, imaging standards, and clinical applications in ultrasound and machine learning, proactively proposing innovative solutions. Collaborate with QA teams to perform verification and validation (V&V) activities, integration testing, and implement end‑to‑end test automation. Partner with manufacturing and other teams to ensure seamless design transfer and sustained high‑quality performance in the field. Monitor and improve product quality by investigating operational challenges and applying root‑cause analysis and creative engineering solutions. Lead efforts to solve field and manufacturing issues through in‑depth failure analysis and iterative design improvements. Manage CAPA projects proactively and effectively address quality and compliance concerns across the product lifecycle. Communication & Cross‑Functional Collaboration Build strong, trustworthy relationships across the company through clear, effective communication. Continuously improve interpersonal and communication skills to better collaborate with staff, executives, clinicians, product managers, and operations teams. Actively contribute to a culture of alignment and mutual accountability by fostering open dialogue and shared ownership of results. Qualifications 3–5 years of hands‑on experience in medical ultrasound or imaging product development. Strong beamforming and signal processing expertise; understand the physics and can implement it in code. Proficiency in C#, C++ and Python for real‑time embedded systems and signal processing. Familiarity with automated test frameworks for imaging systems. Understanding of medical device development processes (design controls, V&V, regulatory documentation). Ability to work independently, move fast, and take full ownership of technical deliverables. Strong written and verbal communication skills. You can document your own work and explain it to non‑engineers. Strong analytical and innovative thinker with problem‑solving capabilities. Deep understanding of engineering best practices and rigorous product development methods. Proven experience and solid track record of complex product development and project management, taking products through concept, design, manufacturing, deployment, and ongoing development. Preferred Qualifications Experience with breast imaging or women's health medical devices. Background in radar or sonar signal processing (beamforming principles transfer directly). Familiarity with MATLAB for algorithm prototyping. Experience with cloud providers (AWS/GCP/Azure). Prior experience at a startup or in a fast‑paced, resource‑constrained environment. Experience with Nvidia GPU platforms or edge computing for AI/ML inference is a strong plus. Strong technical and analytical skills in optics, algorithms, mechanical design, electronics, imaging, and software. Experience communicating with and presenting persuasively to peers, the board of directors, and investors. Ability to travel occasionally (15‑20%) for partner meetings, manufacturing site and supplier visits, and domestic and international customer interactions, if needed. Required Education and Training B.S. or M.S. in Electrical Engineering, Biomedical Engineering, Computer Science, or a related field. Equivalent hands‑on industry experience in ultrasound or imaging systems will be considered. Preferred: Ph.D. in any of the above fields. Why Join Us? Be the first imaging leader in a mission‑driven startup transforming women’s health. Own the function end‑to‑end, from strategy to execution, across all areas. Significant exposure to the board and management team, as well as the industry‑leading investors and thought leaders. Work with cutting‑edge AI‑powered imaging technology that is revolutionizing breast cancer detection. Drive investor and market engagement at a crucial stage of company growth. Make a meaningful impact in a company dedicated to saving lives through better breast imaging. Equity & Compensation – ownership in the company’s success, with an equity package aligned with company growth. Salary is market competitive with experience and includes Stock Options, Health Benefits and 401k. Annual Salary Range is $165,000 to $180,000 #J-18808-Ljbffr