Principal Ultrasound Engineer

HISTOSONICS•Plymouth, MN

2d•Hybrid

About The Position

HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties. We offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most. This is a hands-on role. You will prototype, implement, and quantitatively validate imaging algorithms, and set technical direction for external ultrasound partners. Success is measured by demonstrable improvement in the clarity, consistency, and clinical utility of the images physicians rely on to target, guide, and monitor therapy. The role reports to the Associate VP of Research and Advanced Development and is expected to operate with a high degree of independence.

Requirements

Bachelor’s degree in Electrical Engineering, Biomedical Engineering, Computer Science, Physics, or a related technical discipline.
10+ years in diagnostic ultrasound engineering, with a record of acting as a recognized technical authority for imaging on a commercialized product.
At least 4 years must be post-degree industry experience.
Hands-on experience developing and validating ultrasound image processing algorithms, supported by quantitative image quality assessment.
Working knowledge of the full ultrasound signal chain, from transmit sequencing and beamforming through demodulation, detection, scan conversion, and display.
Strong programming ability for algorithm prototyping, with experience taking implementations to production quality.
Direct experience with RF and IQ ultrasound data, phantoms, and image quality test methods.
Demonstrated ability to set technical direction for and manage the deliverables of external OEM or development partners.
Medical device product development experience under design controls (ISO 13485, 21 CFR 820), including driving features through verification and validation in support of regulatory submissions.
Ability to work with minimal day-to-day direction, structuring your own work across two concurrent programs and surfacing decisions and risks early.
Excellent written and verbal communication, with the ability to represent HistoSonics credibly with partner engineering teams and with clinicians.

Nice To Haves

Advanced degree preferred.
Direct experience implementing color and/or power Doppler, including wall filter design, clutter rejection, and flow estimation.
Experience with specialized or non-conventional ultrasound imaging form factors.
Experience integrating OEM ultrasound platforms, including SDK and API-level customization and scan sequence programming.
Experience with therapeutic ultrasound systems (histotripsy, HIFU, or lithotripsy) and with imaging in the presence of acoustic cavitation.
GPU programming experience for real-time imaging pipelines.
Machine learning applied to ultrasound image enhancement or segmentation, and experience with DICOM.
Experience with regulatory submissions for ultrasound-guided or ultrasound-integrated medical devices under FDA 510(k) or De Novo pathways.
Advanced degree (MS or Ph.D.) with a focus on ultrasound imaging, acoustics, or signal/image processing.

Responsibilities

Design, prototype, and validate B-mode image optimization algorithms — speckle reduction, edge detection and enhancement, adaptive filtering, compounding, and dynamic range and gain management.
Own the definition, specification, and acceptance of advanced imaging modes, including color and power Doppler — implementing directly where appropriate, and otherwise driving delivery through a beamformer OEM partner and independently verifying performance against acceptance criteria.
Serve as the imaging subject matter expert during histotripsy treatment, tuning imaging performance for targeting, real-time visualization, treatment monitoring, and post-treatment assessment.
Establish objective image quality methodology — contrast, contrast-to-noise ratio, resolution, penetration, SNR, frame rate, and Doppler sensitivity — using phantoms, tissue models, and clinical data, and convert it into acceptance criteria that carry through design verification.
Set technical direction for external ultrasound OEM and imaging partners, including transducer, beamforming, and front-end system requirements; review implementations, independently evaluate delivered image quality, and drive partner work to program objectives.
Investigate and resolve imaging artifacts and degradation arising from concurrent therapy delivery, including therapy/imaging synchronization and cavitation-induced clutter.
Own imaging-related design control deliverables and support regulatory strategy, including requirements, risk and hazard analysis, verification protocols and reports, bench test protocols, and alignment with applicable IEC 60601-2-37 and FDA guidance.
Provide hands-on imaging support during laboratory, preclinical, and clinical activities, and build imaging literacy across product, clinical, and regulatory teams.
Define the technical architecture and multi-year imaging roadmap across platforms.