Full-Time
Manufacturing Engineer
Posted on 8/19/2025
iSono Health
11-50 employees
Portable automated 3D breast ultrasound system
No salary listed
San Bruno, CA, USA
In Person
 Mechanical Engineering (2) |
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- Bachelor’s degree in mechanical, biomedical, industrial, or materials science engineering (preferred).
- Minimum 3+ years of experience in medical device manufacturing.
- Proficiency in CAD software (e.g., SolidWorks, Pro-Engineer).
- Strong understanding of manufacturing processes (e.g., injection molding, machining, stamping, laser welding, ultrasonic welding).
- Solid foundation in the design, fabrication, and assembly of complex electromechanical assemblies, including knowledge of mechanical assembly techniques and test methods (e.g., gage R&R analysis, DFx, and lean principles).
- Strong technical skills in prototyping, tooling development, process engineering, and troubleshooting.
- Excellent communication skills to effectively interface with technicians, product development, planning, purchasing, regulatory, inspection, clinical marketing, and supplier teams.
- Strong interpersonal skills with the ability to lead and inspire teams.
- Demonstrated ability to balance multiple priorities against aggressive deadlines while maintaining a high degree of quality.
- Define and establish manufacturing processes, procedures, and production layouts for parts and assemblies, ensuring regulatory compliance.
- Provide hands-on leadership, on-the-job training, and technical support for production staff on the production line during production ramp-up.
- Develop and incorporate inspection and test requirements into production plans through the development of process FMEA and other applicable Risk Management documents.
- Design and develop test fixtures for engineering and manufacturing applications.
- Define the as Master Validation Plan and support validation builds and testing.
- Oversee the complete documentation process for DMR and DHR, including manufacturing work instructions, inspection and test specifications, and travelers. Ensure accurate data entry and seamless management within the quality and MRP database platform.
- Identify process and design improvements to reduce manufacturing costs and increase efficiency.
- Provide technical support for failure analysis of discrepant production components, assemblies, equipment/tools, as well as field returns; initiate corrective actions to ensure product quality.
- Offer strategic guidance to leadership on manufacturing build strategies, capacity expansion, and overall operations planning.
- Identify, research, develop, and qualify premier part manufacturers and suppliers; establish supply chain requirements and manage supplier relationships.
- Report on key metrics and KPIs regularly.
- Significant exposure to the board and management team, as well as the industry-leading investors and thought leaders.
- Travel up to 20% as a regular basis
- Experience in electromechanical new product development.
- Background in ISO 13485 medical device manufacturing or a similar regulated industry.
- Experience collaborating with electrical and systems engineers to design automated PCBA test fixtures.
- Proficiency in process characterization and validation using statistical tools.
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'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
6 month growth
↓ -4%1 year growth
↑ 4%2 year growth
↑ 0%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."
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.
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.
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.
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.