Head of Engineering, Ultrasound Systems

isonohealth; Sunnyvale (CA); On-site; USD 170,000 - 205,000; Full time

Benefits offered by this job

Annual bonus

Stock options

Health benefits

Mission-driven work

Job summary

iSono Health is seeking an innovative Head of Engineering to lead the next‑gen breast imaging platform. You’ll drive R&D strategy, own the technology roadmap across ultrasound hardware, AI/ML, and software, and ensure end‑to‑end product development from concept to commercialization.

You will lead design controls, risk management, and V&V under 21 CFR Part 820 / ISO 13485, while delivering high‑performing, manufacturable systems and direct hands‑on engineering for critical components.

Qualifications

• MS or PhD in Biomedical, Electrical, or Mechanical Engineering, Physics, or related field.
• 8–10+ years in medical device or ultrasound product development; shipped products.

Responsibilities

• Define and execute the R&D strategy aligned to commercialization goals and corporate objectives.
• Own the technology roadmap across ultrasound hardware, AI/ML, software, and future platform development.
• Lead end-to-end product development from concept through commercialization, hardware, firmware, transducer, and software integration.
• Own design controls, DHF, risk management (ISO 14971), and V&V planning under 21 CFR Part 820 / ISO 13485.
• Drive product performance, reliability, manufacturability, and usability improvements.
• Develop or advance an AI/ML component: image quality assessment, lesion detection, segmentation, or automated scan optimization.
• Write production-quality code in Python, MATLAB, or C/C++ for signal processing, image reconstruction, or model training pipelines.
• Diagnose and resolve system-level performance failures at the signal, image, and integration level.
• Author technical specifications and design documentation to FDA design control standards.
• Set project priorities, milestones, resource allocation, and development budgets.
• Provide technical oversight of key suppliers and subsystem vendors.

Skills

Ultrasound systems

Signal processing

Python

MATLAB

C/C++

FDA 510(k) / PMA

Design controls

Education

MS or PhD in Biomedical, Electrical, or Mechanical Engineering, Physics

Tools

Embedded systems experience

I​SO 13485 design controls tools

Job description

About iSono Health Inc.

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.

Position Summary

iSono Health is seeking an innovative, hands‑on, and strategic Head of Engineering with expertise in Ultrasound to lead the advancement of our next‑generation breast imaging platform and related technologies. Reporting directly to the CEO, this executive leader will drive product innovation, oversee multidisciplinary engineering and scientific teams, and ensure successful translation of concepts into commercially viable medical devices.

The Head of Engineering (Product development Leader) will be responsible for defining and executing the company’s technology roadmap, managing product development programs, collaborating with clinical and regulatory stakeholders, and building a high‑performing Development Engineering organization capable of supporting iSono Health’s growth through commercialization and future product expansion. The ideal candidate will own and personally deliver at least one major technical component, ultrasound or AI. Not oversee it. Build it.

You’ll own the science, the system, and the ship date, with the startup agility to make all three happen at once. You posses unique blend of scientific leadership, medical device development expertise, systems engineering knowledge. If you want to manage a roadmap from a distance, this isn’t for you. This is a rare seat at a table where the technology you build tomorrow will be read by a radiologist, trusted by a patient, and replicated across thousands of clinics and you’ll have helped design every layer of it. (Founder Mentality)

Technology & product strategy

• Define and execute the R&D strategy aligned to commercialization goals and corporate objectives
• Own the technology roadmap across ultrasound hardware, AI/ML, software, and future platform development
• Identify emerging technologies and innovation opportunities that strengthen iSono's competitive position
• Collaborate with the CEO on strategic planning, investor presentations, and technical due diligence

Product development leadership

• Lead end-to-end product development from concept through commercialization, hardware, firmware, transducer, and software integration
• Own design controls, DHF, risk management (ISO 14971), and V&V planning under 21 CFR Part 820 / ISO 13485
• Drive product performance, reliability, manufacturability, and usability improvements
• Design, prototype, and validate ultrasound system components transducer performance, beamforming pipelines, or acoustic signal processing
• Develop or significantly advance an AI/ML component: image quality assessment, lesion detection, segmentation, or automated scan optimization
• Write production‑quality code in Python, MATLAB, or C/C++ for signal processing, image reconstruction, or model training pipelines
• Run bench‑level experiments, analyze results, and iterate — hands on hardware, not just in meetings
• Diagnose and resolve system‑level performance failures at the signal, image, and integration level
• Author technical specifications and design documentation to FDA design control standards
• Set project priorities, milestones, resource allocation, and development budgets
• Provide technical oversight of key suppliers and subsystem vendors

Clinical & cross‑functional collaboration

• Partner with Regulatory Affairs and Quality to support FDA submissions and international approvals
• Translate clinical needs into technical product requirements; collaborate with radiologists and KOLs
• Work with Operations and Manufacturing on product transfer and scale‑up
• Represent iSono technically in investor, partner, and customer engagements

Team leadership

• Recruit, mentor, and develop a lean, high‑output multidisciplinary R&D team
• Direct contributor first, people leader second — you lead by doing
• Foster a culture of accountability, innovation, and continuous improvement
• Build organizational capability to support current commercialization and future product lines

Required qualifications

• MS or PhD in Biomedical, Electrical, or Mechanical Engineering, Physics, or related field
• 8-10+ years in medical device or ultrasound product development — shipped products, not papers
• Hands‑on ultrasound systems expertise: transducer physics, array design, beamforming, and image reconstruction
• Real‑time signal and image processing
• Proficiency in Python or MATLAB for simulation, analysis, and algorithm development
• Experience diagnosing and resolving system‑level performance issues
• Proven track record through FDA 510(k), De Novo, or PMA clearance
• Strong command of design controls, ISO 13485, and ISO 14971 — ownership, not oversight

Preferred qualifications

• Familiarity with IEC 62304, IEC 60601, and cybersecurity requirements for software‑driven medical devices
• C/C++ or embedded systems experience — for effective collaboration with software teams
• Experience with automated or robotic imaging systems
• AI/ML‑enabled medical device development
• Startup or early‑stage company experience, you’ve worn multiple hats and thrived

Compensation & benefits

• Base Salary: $170,000 - $205,000
• Eligible for annual bonus plan and stock‑based compensation, subject to company performance and board approval
• Comprehensive health benefits
• Opportunity to build category‑defining technology with direct patient impact

Who we are

iSono Health is a high‑growth, early commercial company at the intersection of physical AI, 3D imaging, and quantitative ultrasound, a Virtual Sonographer Engine. Our first product, ATUSA, is the world's first wearable, FDA‑cleared, AI‑powered automated 3D breast ultrasound platform, actively deployed in real clinics. We are building the world's largest longitudinal breast imaging data platform because we believe the next breakthrough in breast cancer outcomes isn't a new drug, it's knowing what changed, in which patient, and when. We made it easy, accessible, and economical to capture breast images anywhere patients are as simple as a blood pressure cuff.

Every scan we take is a data point in a story that can save a life. We're here to write that story at population scale, accessible, reimbursed, and aligned with the standard of care.

We were building on physical AI before it became a VC dinner party topic. The hidden gem of medical imaging is finally impossible to ignore and we've been in the room for years.

Who we are as a team

We're scrappy, optimistic, and fast. We move with urgency and we don't cut corners, those two things coexist here because we insist on it. We speak our minds. We put patients and providers first, always. We believe in rigorous science and innovative ways of answering hard questions as the foundation for everything we build, and we love what we do. This isn't a job. It's a mission with a deadline.