Representative Engineering Experience

MEDICAL DEVICE Program: Research / R&D Lab / Clinical research

Multi-Channel EEG Monitoring Platform

Why this matters: Demonstrates high-channel biomedical signal acquisition and real-time data streaming—relevant for federal R&D and research instrumentation programs requiring clinical-grade signal quality.

Relevant: analog front-end FPGA data streaming signal processing biomedical instrumentation

Problem

Research organization required high-density brain signal acquisition with clinical-grade signal quality, simultaneous multi-channel recording, and real-time data streaming capability.

Solution

Developed custom analog front-end with instrumentation amplifiers, 24-bit ADC array, FPGA-based signal preprocessing, and TCP/IP streaming interface. Implemented adaptive filtering and artifact rejection algorithms.

Outcome

Sub-microvolt input-referred noise achieved
64-channel simultaneous acquisition
Real-time streaming at 2kHz per channel
Designed to support the FDA 510(k) regulatory submission pathway.
Designed to support clinical-grade EEG data acquisition and analysis workflows.

CONNECTED SYSTEMS Program: Legacy modernization Medical device / regulated

ECG System Architecture Modernization

Why this matters: Shows ability to modernize legacy medical systems while preserving regulatory continuity—relevant for primes and agencies refreshing legacy medical or monitoring systems.

Relevant: legacy modernization wireless connectivity firmware regulatory continuity

Problem

Legacy cardiac monitoring system required component obsolescence mitigation and modern wireless connectivity while maintaining regulatory compliance documentation.

Solution

Redesigned analog front-end with pin-compatible replacements, added BLE 5.0 connectivity module, implemented secure data transmission protocol, and updated firmware architecture for OTA capability.

Outcome

Component obsolescence fully resolved
Secure BLE 5.0 connectivity implemented
Designed to align with FDA substantial equivalence evaluation processes.
5-year component availability secured

MEDICAL DEVICE Program: Product development Connected health / wearable

Vital Signs Wearable Platform

Why this matters: Combines low-power sensing, mobile app, and validation—relevant for connected health, federal wellness/readiness, or SBIR/STTR wearable/remote monitoring programs.

Relevant: low-power sensing mobile app connected health validation

Problem

Medical technology company needed continuous vital signs monitoring platform with extended battery operation and medical-grade accuracy for SpO2, heart rate, and skin temperature.

Solution

Designed ultra-low-power sensor interface, implemented duty-cycling measurement strategy, developed custom optical sensor module, and created companion mobile application for data review.

Outcome

7-day continuous battery operation
Designed to support medical-grade SpO2 measurement accuracy requirements.
IP67 enclosure design completed
Engineering development conducted with consideration for the FDA De Novo regulatory pathway.

MEDICAL DEVICE Program: Therapeutic device Safety-critical / IEC-aligned

Closed-Loop Thermal Therapy System

Why this matters: Demonstrates control systems, redundant safety, and treatment logging—relevant for therapeutic or safety-critical medical device programs and IEC-aligned design.

Relevant: control systems redundant safety treatment logging IEC-aligned design

Problem

Therapeutic device program required precision temperature control system with redundant safety architecture and comprehensive treatment logging for regulatory submission.

Solution

Developed PID control algorithm with adaptive gain scheduling, implemented dual-redundant temperature monitoring, designed fail-safe heating element control, and created treatment session management software.

Outcome

±0.3°C temperature regulation accuracy
Dual-redundant safety architecture
Complete treatment audit trail
IEC 60601-1 compliance verified