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iSono Health

Portable automated 3D breast ultrasound system

Lead Ultrasound Imaging Engineer - AI & Systems

Biomedical Engineering & Medical DevicesUpdated on Nov 11
Full-timeSunnyvale, CA, USAIn-person

About the Job

Requirements

  • Three to five years of hands-on experience in medical ultrasound or imaging product development.
  • Strong beamforming and signal-processing expertise, including understanding the physics and ability to implement it in code.
  • Familiarity with automated test frameworks for imaging systems.
  • Understanding of medical device development processes, including design controls, verification and validation, and regulatory documentation.
  • Ability to work independently, move quickly, and own technical deliverables.
  • Strong written and verbal communication skills, including documenting work and explaining it to non-engineers.
  • Strong analytical and innovative thinking and problem-solving capabilities.
  • Deep understanding of engineering best practices and rigorous product development methods.
  • Proven experience developing complex products and managing projects through concept, design, manufacturing, deployment, and ongoing development.
  • A 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.

Responsibilities

  • Take ownership of critical imaging initiatives from concept to execution, drive technical decisions, prototype rapidly, and guide system development across mechanical, electrical, and algorithmic domains.
  • Lead hands-on development of Gen 2 hardware and software upgrades to the ultrasound imaging system.
  • Design, implement, and optimize beamforming algorithms and real-time signal-processing pipelines.
  • Integrate and evaluate Nvidia and other GPU platforms, including 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 support robust design transfer to manufacturing.
  • Contribute to intellectual-property generation and design-control documentation aligned with FDA and global medical-device standards.
  • Set product-development priorities by connecting technical focus to customer needs.
  • Own project planning, execution, and delivery; anticipate risks, resolve challenges, and maintain alignment with schedule, scope, and budget alongside cross-functional partners.
  • Serve as a product sponsor and champion by providing technical and business leadership to project teams and participating in business and design-control review boards.
  • Ensure rigorous design documentation and robust verification and validation aligned with customer expectations and quality standards.
  • Support regulatory submissions through documentation and ensure product design aligns with global compliance requirements.
  • Generate and document intellectual property throughout product development to secure core innovations and long-term competitiveness.
  • Lead implementation of advanced software-based quantitative ultrasound beamforming techniques, emphasizing real-time performance and clinical-grade image quality.
  • Develop and optimize algorithms for image acquisition, processing, and enhancement, including machine-learning-based solutions.
  • Design and lead ultrasound reader studies to evaluate imaging performance; prepare reports and documentation for internal stakeholders and regulatory bodies.
  • Stay current on emerging technologies, imaging standards, and clinical applications in ultrasound and machine learning, and propose innovative solutions.
  • Collaborate with QA teams on verification and validation, integration testing, and end-to-end test automation.
  • Partner with manufacturing and other teams on design transfer and sustained high-quality field performance.
  • Monitor and improve product quality by investigating operational challenges and applying root-cause analysis and engineering solutions.
  • Lead resolution of field and manufacturing issues through failure analysis and iterative design improvements.
  • Manage CAPA projects and address quality and compliance concerns across the product lifecycle.
  • Build relationships across the company through clear communication and collaborate with staff, executives, clinicians, product managers, and operations teams.
  • Contribute to organizational alignment and mutual accountability by fostering open dialogue and shared ownership of results.

Desired Qualifications

  • Experience with breast imaging or women's health medical devices.
  • Background in radar or sonar signal processing.
  • Familiarity with MATLAB for algorithm prototyping.
  • Experience with cloud providers such as AWS, GCP, or Azure.
  • Exposure to JavaScript/TypeScript and the Node stack.
  • 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.
  • 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.
  • A PhD in Electrical Engineering, Biomedical Engineering, Computer Science, or a related field.

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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