Position SummaryiSono 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
The pay range for this role is:
170,000 - 205,000 USD per year (Sunnyvale, CA)
