Product Verification Engineer — Ultrasound Device

Location: U.S. (Boston)

About Sonologi

Sonologi Inc. is a medical technology company focused on advancing wearable ultrasound imaging for proactive disease monitoring and personalized care. Our technology integrates miniaturized ultrasound electronics, wearable bioadhesive transducer systems, and advanced software analytics to enable hands-free visualization of deep anatomical structures — including the cardiac, pulmonary, and vascular regions — built upon foundational research from the Massachusetts Institute of Technology.

Our vision is to shift healthcare from reactive intervention toward proactive, data-driven disease management through accessible and scalable wearable imaging technologies.

The Role

We are seeking a hands-on and technically rigorous Verification Engineer to support the assembly, characterization, and regulatory compliance testing of the Sonologi™ Wearable Ultrasound System as we progress toward FDA 510(k) clearance. This individual will work at the intersection of hardware, physics, and regulatory testing — building and operating test setups, assembling prototype devices, and coordinating with external testing laboratories for EMC and electrical safety qualification.

This is a doing role — ideal for someone with a strong foundation in applied physics or electronic engineering who enjoys working with real hardware, diagnosing system behavior at the bench, and translating test results into clear, defensible engineering records. You will play a central role in taking the Sonologi device from engineered prototype to a submission-ready, compliance-tested system.

Key Responsibilities

Device Assembly & Bench Characterization

• Assemble and prepare ultrasound device units for testing, including wearable patch integration, transducer connection, acquisition system setup, and mobile display configuration

• Set up and operate bench test environments to characterize device performance across key parameters: image quality, acoustic output, signal integrity, and power management

• Execute functional verification tests covering B-mode, M-mode, Color Doppler, and Pulsed Wave imaging modes per defined test protocols

• Document assembly procedures, test configurations, and results with accuracy and traceability in support of the Design History File (DHF)

• Identify and troubleshoot hardware and system-level anomalies, working with electrical and software engineers to isolate root causes

Device Performance Testing

• Execute and document device performance test protocols including acoustic output characterization, ultrasound field mapping, and image quality assessment per IEC 60601-2-37 and IEC 62359

• Perform electrical characterization of the acquisition system including power consumption profiling across operating modes (scan, standby, charge) and battery life validation

• Conduct environmental and stress testing including IP68 water ingress validation, temperature range testing, and mechanical durability assessments

• Support usability and human factors bench testing as required by IEC 62366, documenting device behavior under representative use scenarios

• Maintain detailed test records, anomaly logs, and pass/fail reports in a format suitable for regulatory submission

EMC & Electrical Safety Testing Coordination

• Prepare device test packages for external EMC and electrical safety laboratories, including test configuration descriptions, block diagrams, applied part specifications, and safety-relevant component lists

• Coordinate device shipment, setup instructions, and pre-test documentation to ensure laboratory testing starts on schedule

• Attend external laboratory testing sessions as the on-site technical representative, supporting test setup, operating the device, and responding to engineer queries in real time

• Review draft EMC and safety test reports for technical accuracy; compile and track responses to laboratory deficiency notices or follow-up requests

• Support re-test coordination if initial test results require design modifications or test condition clarifications

Test Documentation & Engineering Records

• Author and maintain verification test protocols, test reports, and traceability records linking test results to device requirements and risk controls

• Contribute to the technical documentation package for 510(k) submission, including performance testing summaries, test configuration descriptions, and acoustic output data

• Support preparation of the essential performance identification record and single fault condition analysis documentation for IEC 60601-1 compliance

• Maintain organized and audit-ready engineering records throughout the verification lifecycle

Required Qualifications

• Bachelor’s or Master’s degree in Physics, Electronic Engineering, Electrical Engineering, Biomedical Engineering, or a closely related field

• 2–5 years of hands-on experience in device verification, hardware testing, or engineering validation in a medical device or electronics environment

• Practical experience assembling and testing electronic hardware systems at the bench level

• Understanding of EMC testing principles and electrical safety standards, including familiarity with IEC 60601-1

• Experience with signal measurement equipment: oscilloscopes, spectrum analyzers, network analyzers, or ultrasound field measurement systems

• Strong technical writing skills for producing clear, traceable test protocols and engineering reports

• Comfortable working in a startup environment where test procedures, tools, and setups may need to be built from scratch

• Fluency in both English and Chinese (Mandarin) preferred, supporting collaboration with hardware and manufacturing partners

Preferred Experience

• Background in ultrasound physics, acoustic measurement, or medical imaging systems

• Hands-on experience with IEC 60601-2-37 or IEC 62359 ultrasound-specific testing

• Prior experience attending or coordinating external EMC or electrical safety laboratory sessions

• Familiarity with IP-rated enclosure testing or environmental stress testing methods

• Experience with wireless system characterization including Wi-Fi (2.4G/5G) interference and coexistence testing

• Knowledge of ISO 14971 risk management and how test results feed into risk control verification

• Exposure to FDA 510(k) submission processes and the role of performance testing in regulatory evidence packages

Pay: $70,000.00 - $120,000.00 per year

Work Location: In person