Head of Engineering, Ultrasound Systems

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. 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 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 Startup or early‑stage company experience, you've worn multiple hats and thrived Eligible for annual bonus plan and stock‑based compensation, subject to company performance and board approval Opportunity to build category‑defining technology with direct patient impact 170,000 - 205,000 USD per year (Sunnyvale, CA) #J-18808-Ljbffr iSono Health Inc.