Head of Ultrasound Engineering & AI Platform

isonohealth; Sunnyvale (CA); On-site; USD 170,000 - 205,000; Full time

Benefits offered by this job

Annual bonus

Stock options

Health benefits

Mission-driven work

Job summary

iSono Health is seeking an innovative Head of Engineering to lead the next‑gen breast imaging platform. You’ll drive R&D strategy, own the technology roadmap across ultrasound hardware, AI/ML, and software, and ensure end‑to‑end product development from concept to commercialization.

You will lead design controls, risk management, and V&V under 21 CFR Part 820 / ISO 13485, while delivering high‑performing, manufacturable systems and direct hands‑on engineering for critical components.

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.

Responsibilities

• 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.
• 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.
• Develop or 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.
• 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.

Skills

Ultrasound systems

Signal processing

Python

MATLAB

C/C++

FDA 510(k) / PMA

Design controls

Education

MS or PhD in Biomedical, Electrical, or Mechanical Engineering, Physics

Tools

Embedded systems experience

I​SO 13485 design controls tools

Job description

iSono Health is seeking an innovative Head of Engineering to lead the next‑gen breast imaging platform. You’ll drive R&D strategy, own the technology roadmap across ultrasound hardware, AI/ML, and software, and ensure end‑to‑end product development from concept to commercialization.

You will lead design controls, risk management, and V&V under 21 CFR Part 820 / ISO 13485, while delivering high‑performing, manufacturable systems and direct hands‑on engineering for critical components.