Full-Time

Head Product Development and Imaging

Posted on 10/31/2025

iSono Health

iSono Health

11-50 employees

Portable automated 3D breast ultrasound system

No salary listed

San Bruno, CA, USA

In Person

Travel 15-20% domestically and internationally for partner meetings, manufacturing sites, and supplier visits.

Category
Engineering Management (1)
Required Skills
Python
Data Structures & Algorithms
Machine Learning
MATLAB
C/C++
Requirements
  • At least 10+ years of design engineering experience in ultrasound or imaging product development.
  • Proven expertise in beamforming techniques, ultrasound image processing, and image quality enhancement.
  • Strong programming skills (e.g., Python, C++, MATLAB) with experience in ultrasound-specific software development and frameworks.
  • Strong analytical and innovative thinker with problem-solving capabilities.
  • Excellent oral and written communication and collaboration skills.
  • Ability to work in a dynamic and fast-paced environment.
  • Strong technical and analytical skills in optics, algorithms, mechanical design, electronics, imaging, and software.
  • Deep understanding of engineering best practices and rigorous product development methods.
  • Proven experience and solid track record of complex product development and project management, taking products through concept, design, manufacturing, deployment, and ongoing development.
  • 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.
  • Master’s or Ph.D. in Computer Science, Electrical Engineering, Software Engineering, Mechanical Engineering, Imaging Science, or a related engineering discipline. Commensurate work experience in ultrasound/vision engineering will be preferred.
Responsibilities
  • Take ownership of critical imaging initiatives from concept to execution, driving technical decisions, prototyping rapidly, and guiding system development across mechanical, electrical, and algorithmic domains.
  • While this role may begin as an individual contributor, the ideal candidate brings prior leadership experience and is prepared to scale into managing and mentoring engineers as the team grows.
  • Set appropriate priorities for product development by connecting technical focus to key customer needs.
  • Own the planning, execution, and delivery of projects—anticipating risks, resolving challenges, and maintaining alignment with schedule, scope, and budget alongside cross-functional partners.
  • Be a product sponsor and champion by offering sound technical and business leadership to project teams and actively participating in business and design control review boards.
  • Ensure rigorous design documentation and execution of robust verification and validation processes aligned with customer expectations and quality standards.
  • Deliberately support regulatory submissions by contributing to documentation and ensuring product design aligns with global compliance requirements.
  • Generate and document meaningful IP throughout product development to secure core innovations and long-term competitiveness.
  • Lead the execution and implementation of advanced, software-based quantitative ultrasound beamforming techniques, with a strong emphasis on real-time performance and clinical-grade image quality.
  • Develop and optimize novel algorithms for image acquisition, processing, and enhancement—including machine learning-based solutions.
  • Design and lead ultrasound reader studies to evaluate imaging performance; prepare comprehensive reports and documentation for internal stakeholders and regulatory bodies.
  • Stay up to date on emerging technologies, imaging standards, and clinical applications in ultrasound and machine learning, proactively proposing innovative solutions.
  • Collaborate with QA teams to perform verification and validation (V&V) activities, integration testing, and implement end-to-end test automation.
  • Create a high-performing, positive, and values-driven team culture that emphasizes excellence, creativity, and accountability.
  • Foster an environment that encourages innovative thinking and risk-taking to deliver breakthrough product designs with strong scalability.
  • Use sound judgment to navigate complex situations with professionalism, humility, and ethical integrity.
  • Promote continuous improvement in design and development processes through deliberate measurement and refinement.
  • Assess individual performance, provide coaching and mentorship, and support career growth—both technical and managerial—aligned with business goals and employee aspirations.
  • Contribute to team planning, staffing decisions, budgeting, and program cost tracking.
  • Partner with manufacturing and field service teams to ensure seamless design transfer and sustained high-quality performance in the field.
  • Monitor and improve product quality by investigating operational challenges and applying root-cause analysis and creative engineering solutions.
  • Lead efforts to solve field and manufacturing issues through in-depth failure analysis and iterative design improvements.
  • Manage CAPA projects proactively and effectively address quality and compliance concerns across the product lifecycle.
  • Build strong, trustworthy relationships across the company through clear, effective communication.
  • Continuously improve interpersonal and communication skills to better collaborate with staff, executives, clinicians, product managers, and operations teams.
  • Actively contribute to a culture of alignment and mutual accountability by fostering open dialogue and shared ownership of results.
Desired Qualifications
  • Experience in medical device design and development, specifically breast tissue visualization.
  • Commensurate work experience in ultrasound/vision engineering will be preferred.

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

San Francisco, California

Founded

2014

Simplify Jobs

Simplify's Take

What believers are saying

  • AUDIBLE Study at UC Davis, City of Hope validates performance against mammography.
  • Abdul Latif Jameel partnership launches ATUSA in Nigeria's underserved market.
  • Series A opened at JPMorgan Week 2026 accelerates global deployments.

What critics are saying

  • AUDIBLE Study fails validation in 6-12 months, blocking reimbursements.
  • GE HealthCare's Senographe Pristina captures dense breast market in 12-24 months.
  • Slow Series A close amid funding winter forces dilution in 6-12 months.

What makes iSono Health unique

  • ATUSA is world's first FDA-cleared wearable automated 3D breast ultrasound scanner.
  • Operator-independent scanning captures full breast volumes in two minutes per breast.
  • USaaS model combines hardware, AI, and consumables for recurring revenue.

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Benefits

Flexible Work Hours

Growth & Insights and Company News

Headcount

6 month growth

-4%

1 year growth

4%

2 year growth

0%
ICE Service Community
Jan 16th, 2026
iSono Health Launches World's First Wearable, Automated, Portable, FDA-Cleared Breast Ultrasound Platform

iSono Health launches world's first wearable, automated, portable, fda-cleared breast ultrasound platform. iSono Health, a pioneer in women's health imaging, has announced the commercial launch of ATUSA, an FDA-cleared, wearable, and automated 3D quantitative breast ultrasound platform. Designed to bring high-quality imaging into everyday clinics, ATUSA unlocks the $14 billion U.S. breast imaging market by eliminating reliance on hard-to-find skilled sonographers and cost-prohibitive equipment. A graduate of Y Combinator and the Texas Medical Center Accelerator, iSono Health has gained significant industry recognition, including the HLTH 2025 Rising Star (Diagnostics) and the WISH 2024 Global Awards. Building on this commercial launch, the company is also announcing the opening of its Series A financing at its inaugural Next Horizon Summit during JPMorgan Week to accelerate global deployments and advance its AI-driven "sentient partner" roadmap toward machine-as-the-expert breast imaging robotics. Standard mammography often fails the 40 million American women with dense breast tissue, creating a massive diagnostic gap where cancers can remain hidden. It can be a painful experience and often exposes women to unnecessary X-ray radiation, leaving those of reproductive age with limited screening options. ATUSA can fundamentally change the economics and accessibility of breast health through a unique fusion of wearable hardware and cloud-based intelligence: * Automated Scanning: Utilizing a wearable, hands-free accessory, ATUSA(TM) captures full 3D volumes in approximately two minutes per breast, roughly 10x faster than manual handheld ultrasound. This ensures consistent and repeatable images are generated, regardless of the operator's skill level. * Point-of-Care Integration: The system empowers OB/GYNs and primary care providers to offer specialist-level imaging directly in their offices, generating standardized 3D whole-breast visualization directly at the point of care. * USaaS Business Model: A scalable "Ultrasound-as-a-Service" model that combines the wearable hardware, cloud-based AI, and consumables to create a recurring revenue stream while lowering the barrier to entry for local clinics. * Advanced "Sentient" AI: iSono Health is working to move beyond simple detection toward a "sentient partner" model, where the system utilizes acoustic biomarkers and machine learning to sense patient-specific needs and provide real-time diagnostic support. "ATUSA(TM) is a system-wide upgrade for women's breast health," said Neda Razavi, CEO of iSono Health. "We are putting the power of a world-class radiology suite into the hands of local clinicians, replacing slow, manual workflows with real-time diagnostic images at the point of care." A core pillar of the ATUSA launch is the initiation of the AUDIBLE Study, a pivotal multicenter clinical trial supported by a grant from the National Institutes of Health (NIH). This 800-patient study is designed to evaluate the diagnostic performance of the ATUSA(TM) platform compared to traditional mammography and MRI. * AI Products Validation: Assessing the performance of iSono's machine-learning algorithms in identifying and classifying abnormal masses. * Operator Independence: Proving that the automated, wearable hardware provides consistent, high-fidelity 3D volumes regardless of the user's clinical background. The study is being conducted at leading medical institutions, including UC Davis, Veda Trials (Axia Women's Health), and City of Hope, ensuring the technology is vetted by the nation's top oncology and radiology experts. "What we need are imaging solutions that are easy to use, require minimal training, and can be brought directly into communities," said Dr. John R. Scheel, M.D., Ph.D., M.P.H., Vice Chair of Global Health, Department of Radiology at Vanderbilt University Medical Center. "Wearable, operator-independent ultrasound technologies have the potential to dramatically improve access, speed, and accuracy, especially for women with dense breasts."

Business Wire
Jan 14th, 2026
iSono Health launches ATUSA, world's first wearable automated breast ultrasound, backed by $14.7M funding

iSono Health has launched ATUSA, the world's first FDA-cleared wearable, automated breast ultrasound platform, and is opening its Series A funding round during JPMorgan Healthcare Week. The company aims to address the $14 billion US breast imaging market by eliminating dependence on skilled sonographers and expensive equipment. ATUSA captures full 3D breast volumes in approximately two minutes per breast through automated scanning, roughly 10 times faster than manual ultrasound. The system enables primary care providers and OB/GYNs to offer specialist-level imaging directly in their offices through an "Ultrasound-as-a-Service" model. iSono Health has raised $14.7 million to date, including a recent $3 million seed round led by Draper Associates and Transform VC, plus $3.7 million in non-dilutive funding from NIH, NSF and NCI. The company is conducting the 800-patient AUDIBLE Study across leading medical institutions.

IT Juzi
Oct 21st, 2025
iSono Health Secures $3M Seed Funding

iSono Health, a company providing 3D ultrasound imaging devices for breast cancer monitoring, has secured $3 million in seed funding. The device allows women to perform monthly breast checks at home without radiation, taking only two minutes per session.

AIN
Oct 14th, 2025
About iSono Health

iSono Health will use the new funding to further develop its ATUSA automated 3D breast ultrasound system, expand clinical validation through NIH-funded studies, and scale its technology to make preventive breast exams faster, more accessible, and widely available globally.

Vestbee
Oct 14th, 2025
iSono Health secures $5M for breast screening

JSK Investments Group has funded US startup iSono Health, creator of the ATUSA™, a 3D breast ultrasound system. The funding round, led by JSK, will help iSono Health expand its system's reach, enhance AI image analysis, and support NIH-backed studies. iSono Health secured approximately $5 million in early 2025. The partnership aims to make breast screening more accessible globally.

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