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iSono Health

Portable automated 3D breast ultrasound system

Head of Engineering - Ultrasound Systems

Engineering LeadershipUpdated on Nov 14
Full-timeSunnyvale, CA, USAIn-person

About the Job

Requirements

  • A Master of Science or PhD in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Physics, or a related field.
  • At least 8 years of experience in medical device or ultrasound product development, including shipped products.
  • Hands-on expertise in ultrasound systems, including transducer physics, array design, beamforming, and image reconstruction.
  • Experience with 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.
  • A proven track record obtaining FDA 510(k), De Novo, or PMA clearance.
  • Strong command of design controls, ISO 13485, and ISO 14971, with ownership experience.

Responsibilities

  • Define and execute the R&D strategy aligned with commercialization goals and corporate objectives.
  • Own the technology roadmap across ultrasound hardware, artificial intelligence and machine learning, software, and future platform development.
  • Identify emerging technologies and innovation opportunities that strengthen the company'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, including hardware, firmware, transducer, and software integration.
  • Own design controls, the design history file, risk management under ISO 14971, and verification and validation planning under 21 CFR Part 820 and ISO 13485.
  • Drive product performance, reliability, manufacturability, and usability improvements.
  • Design, prototype, and validate ultrasound system components, including transducer performance, beamforming pipelines, or acoustic signal processing.
  • Develop or significantly advance an artificial intelligence or machine learning component, such as 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 on hardware directly.
  • Diagnose and resolve system-level performance failures at the signal, image, and integration levels.
  • 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.
  • Partner with Regulatory Affairs and Quality to support FDA submissions and international approvals.
  • Translate clinical needs into technical product requirements and collaborate with radiologists and key opinion leaders.
  • Work with Operations and Manufacturing on product transfer and scale-up.
  • Represent the company technically in investor, partner, and customer engagements.
  • Recruit, mentor, and develop a lean, high-output multidisciplinary R&D team.
  • Lead by doing as a direct contributor while also serving as a people leader.
  • Foster a culture of accountability, innovation, and continuous improvement.
  • Build organizational capability to support current commercialization and future product lines.

Desired Qualifications

  • Familiarity with IEC 62304, IEC 60601, and cybersecurity requirements for software-driven medical devices.
  • C/C++ or embedded systems experience to collaborate effectively with software teams.
  • Experience with automated or robotic imaging systems.
  • Experience developing artificial intelligence or machine learning-enabled medical devices.
  • Startup or early-stage company experience, including working across multiple functions.

About the Company

iSono Health

Portable automated 3D breast ultrasound system

Isono Health makes a portable, automated 3D breast ultrasound system called ATUSA. It lets clinicians screen and monitor breast cancer without needing a trained ultrasound operator by combining a wearable accessory, a 3D scanner, a Windows app for real-time image display, and a secure web app for remote viewing. The system standardizes and speeds up whole-breast image acquisition and analysis, reportedly delivering results 15-20 times faster than manual probing. It targets high-risk patients who need personalized, accessible monitoring and markets to hospitals, clinics, and individual healthcare providers. Revenue comes from selling the ATUSA hardware and software, with potential additional income from subscription-based remote monitoring services. Compared with traditional ultrasound options, ATUSA emphasizes automation, portability, standardized imaging, and remote data access, reducing dependence on operator expertise and enabling broader screening and follow-up.

Company size
11-50
Company stage
Seed
Total funding
$6.6M
Headquarters
Sunnyvale, CA
Founded
2014

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