Established software revision control and git-ops for test software configuration management, enabling proper version tracking and change control for Class III medical device production test systems. Non-product software verification and validation was performed in accordance with 21 CFR 820.70(i) to satisfy FDA quality system requirements.
Developed LabVIEW-based data acquisition integration for left ventricular assist device (LVAD) production test systems, enabling automated measurement and recording of device performance parameters. Non-product software verification and validation was performed in accordance with 21 CFR 820.70(i) to satisfy FDA quality system requirements.
Performed code review, maintenance, and refactoring of existing LabVIEW test set source code for a Class III implantable LVAD manufacturer to improve reliability, maintainability, and compliance with quality system requirements. Non-product software verification and validation was performed in accordance with 21 CFR 820.70(i) to satisfy FDA quality system requirements.
Developed operational support procedures for LVAD production test equipment, documenting standard operating procedures to ensure consistent and reliable test execution for Class III medical device manufacturing. Non-product software verification and validation was performed in accordance with 21 CFR 820.70(i) to satisfy FDA quality system requirements.
Developed pump programming and test software for LVAD device production, enabling automated programming and verification of implantable cardiac pump parameters. Non-product software verification and validation was performed in accordance with 21 CFR 820.70(i) to satisfy FDA quality system requirements for Class III medical device production testing.
Provided LabVIEW troubleshooting and support services for the client. Diagnosed and resolved software issues in their LabVIEW-based systems across multiple engagements, ensuring reliable operation of their manufacturing and test processes.
Duplicated the torque motor test bench to provide additional production testing capacity for refurbished avionics subsystem components.
Performed ongoing torque motor test bench maintenance, calibration support, and feature development for avionics subsystem refurbishment testing. The LabVIEW-based system incorporated high-pressure pneumatic plumbing, Alicat flow meters, and pressure controllers.
Diagnosed and resolved software defects in the torque motor test bench system to restore reliable operation of avionics subsystem testing for Boeing 737 components.
Developed a test set and LabVIEW software for IC/MEMS semiconductor production. Built automated test and measurement systems for semiconductor device characterization and production testing.
Modernized LabVIEW test software for MRI compatibility test equipment for a class III implantable medical device, upgrading to current platform versions and improving test throughput and measurement accuracy for active implantable medical device testing. Test method verification and validation was performed in accordance with 21 CFR 820.70(i) to meet FDA quality system requirements.
Designed and developed an RF test set to automate verification and validation of MRI compatibility for Class III rechargeable Active Implantable Medical Devices (AIMDs). This project addressed the critical need to characterize how implantable devices interact with MRI electromagnetic fields, ensuring patient safety during MRI scans. The automated test system measured RF-induced heating, electromagnetic interference, and device functionality under simulated MRI conditions. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i) to satisfy FDA quality system requirements.
Designed and developed an RF injection system for simulating MRI field conditions during active implantable medical device compatibility testing. The system enabled characterization of RF-induced heating, electromagnetic interference, and device functionality under simulated MRI conditions. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i).
Designed and built a five-axis robotic arm test set for near-field inductive charging characterization of a class III active implantable medical device. This complex electromechanical test system enabled precise spatial mapping of the charging field around the implant, characterizing power transfer efficiency across multiple orientations and distances. The project included full non-product software validation per 21 CFR 820.70(i) and comprehensive test method validation to ensure measurement accuracy and regulatory compliance.
Extended the real estate market analytics platform with additional query filters and reporting capabilities for identifying buy-side single and multifamily real estate targets.
Further enhanced the real estate query software with refined market survey criteria and automated target identification for the private equity acquisition pipeline.
Developed client monitoring and control system for satellite communication and defense solutions.
Performed browser software updates for the client's satellite communication systems to maintain security and compatibility.
Developed medium TDC software for satellite communication terminal equipment.
Migrated satellite communication system software to Windows 10, ensuring continued operation and compatibility with modern operating systems.
Developed the novel optical inspection system for transparent contact lens mold quality verification. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i).
Built automated cosmetic inspection capabilities to detect surface defects and occlusions in transparent contact lens molds using novel optical imaging techniques including angle of attack, refraction, and light scatter analysis. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i).
Provided engineering support for emissions compliance of the inspection system equipment.
Designed and built the physical enclosure and housing for the contact lens mold inspection system.
Upgraded automated visual inspection system with significantly improved defect detection accuracy and production throughput for transparent contact lens mold inspection. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i).
Designed inspection system architecture incorporating lessons learned from previous generations to improve defect detection in translucent molds.
Delivered operator training for the automated wafer/mold inspection system to ensure proper use and maintenance by production staff.
Developed test software for an avionics product, part of a broader portfolio of over 15 projects spanning a decade supporting products used in passenger jet cockpits and Army tank crew compartments.
Designed and developed the AMIS (Advanced Multi-function Indicator System) tester for validating AMIS avionics displays used in military and commercial aircraft applications.
Developed an ARINC 429 protocol test system. ARINC 429 is the primary data bus standard for commercial and transport aircraft avionics. The test set verified proper ARINC communication, data formatting, and protocol compliance.
Built a force measurement test set to characterize and validate the tactile response of cockpit switches and controls, measuring actuation force profiles to ensure avionics input devices met specification requirements.
Provided general engineering support services across the client's portfolio of avionics test and production systems, including troubleshooting, maintenance, and ad-hoc development.
Developed a test system for multiple Solid-State Relay (SSR) testing, validating switching performance, isolation, and reliability of solid-state relays used in avionics power distribution and control systems.
Developed Phase 2 test and measurement capabilities for an avionics tester with expanded test coverage for digital display functionality and communication interfaces.
Designed and developed an automated tester for validating avionics products including digital displays and cockpit instrumentation.
Developed the second phase of the avionics test program with expanded test coverage and environmental compliance verification.
Built the initial automated test system for Panel Mount Product (PMP) electrical, optical, and mechanical verification for aircraft cockpit displays and indicators.
Extended PMP testing capabilities to include the RPU (Remote Power Unit) variant of the panel mount avionics product line.
Extended the test program for additional avionics product variants and test requirements.
Designed and built an automated switch tester characterizing electrical contacts, illumination, actuation force, and environmental performance of cockpit switches used in commercial aviation and military applications.
Provided NI TestStand integration and support, standardizing test sequencing, reporting, and data management across multiple avionics test stations.
Produced verification and validation documentation for avionics test programs.
Developed a test set for fire suppression enclosure cabinets used in semiconductor wafer fabrication facilities. These specialized cabinets surround equipment using pyrophoric chemicals that combust on contact with air, creating a vortex containment system to safely manage chemical releases and rated to withstand a building fire for safe personnel evacuation.
Provided LabVIEW support for Acceptance Test Procedure development and execution on the consolidated avionics LRU test set.
Developed test software for the client's inverter system, supporting verification and validation of power conversion equipment for rotorcraft applications.
Provided ongoing software support for a fleet of fatigue test sets designed to autonomously stress helicopter rotor blades and body panels over months-long test durations.
Developed Acceptance Test Procedure (ATP) for consolidated avionics LRU test set.
Maintained and updated the Electronic Equipment Unit test capabilities within the consolidated avionics test set.
Executed a major avionics test set program for a military helicopter, supporting verification and validation of avionics subsystems. Designed new consolidated avionics LRU test set that replaced five end-of-life test sets with a single monolithic system using ITAs and high-density interconnects.
Performed ongoing maintenance and sustaining engineering for the consolidated avionics LRU test set that replaced five end-of-life test sets with a single monolithic system using high-density Mac panel interconnects.
Developed test set for helicopter de-icing subsystem.
Developed a landing gear verification and validation test set for automated testing of landing gear subsystem functionality.
Provided ongoing software support for a fleet of fatigue test sets designed to autonomously stress helicopter rotor blades and body panels over months-long test durations.
Executed a major avionics test set program for a military helicopter, supporting verification and validation of avionics subsystems. Designed new consolidated avionics LRU test set that replaced five end-of-life test sets with a single monolithic system using ITAs and high-density interconnects.
Updated the Flight Control Computer LabVIEW test software to support revised test requirements and hardware configurations.
Developed the data acquisition system for the flow loop, integrating pressure and flow measurement instrumentation for hydrocarbon flow characterization.
Designed and built a high-pressure closed-loop circulating hydrocarbon flow loop system with integrated pressure and flow gauges for characterizing and calibrating measurement instrumentation under simulated operating conditions.
Developed algorithm for a sleep apnea diagnostic startup, processing physiological signals and comparing results against polysomnograph (sleep study) reference data to develop novel diagnostic algorithms.
Updated the embedded CompactRIO (cRIO) control system on a mobile trailer/rig for a tire manufacturer. The upgrades modernized the real-time control and data acquisition system used for tire testing and characterization in field conditions.
Designed and built the foundational LabVIEW test architecture for RFIC/MMIC semiconductor testing for military applications.
Developed a test data database for storing and retrieving RFIC/MMIC measurement results and device characterization data.
Implemented gain compression testing and control capabilities for characterizing RF integrated circuit amplifier performance.
Developed binning algorithms for sorting and classifying MMIC/RFIC devices based on measured performance parameters.
Implemented pulse power measurement capabilities for characterizing MMIC/RFIC device performance under pulsed signal conditions.
Developed S-parameter characterization module for measuring and analyzing RF device scattering parameters.
Built the core semiconductor test software framework for RF integrated circuit production testing and characterization for military applications.
Performed non-product software validation per 21 CFR 820.70(i) for a commercial off-the-shelf (COTS) Learning Management System at a Class II medical device company.
Established CICD pipeline for medical device manufacturing test software. Configured a build server and integrated help file generation into the software development pipeline for the client's test software. Non-product software verification and validation was performed in accordance with 21 CFR 820.70(i) and 21 CFR Part 11 (electronic records and signatures).
Reviewed and assessed existing V&V documentation against FDA regulatory requirements, identifying gaps and remediation priorities. Work was performed in the context of non-product software verification and validation and test method verification and validation per 21 CFR 820.70(i) and 21 CFR Part 11.
Developed unit tests for software module as part of the non-product software V&V effort. Non-product software verification and validation was performed in accordance with 21 CFR 820.70(i) and 21 CFR Part 11.
Developed LabVIEW VI helper utilities to support test software development and maintenance workflows. Work performed in the context of non-product software verification and validation per 21 CFR 820.70(i).
Implemented a structured non-product software V&V methodology. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i) and 21 CFR Part 11 (electronic records and signatures).
Provided consulting on test system V&V strategy and architecture design for the client's manufacturing test infrastructure. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i) and 21 CFR Part 11.
Provided FDA validation advisory services for a company developing Class III Software as a Medical Device (SaMD) for corneal tissue management. The software manages the full chain of custody for cadaver corneas from harvesting through cold-chain transport to implantation. The software verification and validation strategy addressed 21 CFR Part 11 (electronic records and signatures) requirements given the chain-of-custody tracking and tissue suitability documentation demands.
Architected a data synchronization solution for a multi-site healthcare organization operating across approximately 50 states, spanning three projects starting in 2023. The project addressed two incompatible EHR/EMR (Electronic Health Records/Electronic Medical Records) systems, requiring modifications to both platforms to enable communication. The work involved data improvement, data rearchitecture, and medical notes synchronization, laying the groundwork for future AI-driven clinical intelligence initiatives.
Provided engineering support services for the client, supporting their technical product development and test requirements.
Designed an automated inspection solution for a Class II orthopedic implant manufacturer producing shoulder, knee, and hip implants. Initiated in response to a CAPA. Work included uncertainty analysis, Measurement System Analysis (MSA), and design of an in-situ process gauge. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i), including MSA to satisfy FDA quality system requirements.
Integrated barcode scanner technology for automated part tracking and identification in oilfield equipment test operations.
Automated test procedures for new conduit run testing and validation of oilfield flow control equipment.
Developed automated choke test system for characterizing and validating wellhead choke valve performance.
Automation design and development for industrial automation applications.
Developed auto-calibration routines for the two-way radio test equipment, enabling automated RF circuitry tuning and optimization for first responder communications equipment.
Provided software architecture consulting and ongoing development for the LabVIEW-based two-way radio test and calibration equipment platform sold to sheriff offices, police departments, and fire departments.
Maintained on-site frack pump test cell software and hardware for diesel-driven hydraulic fracturing pump testing.
Developed new software features for the frack pump test cell to expand test capabilities and improve production throughput.
Provided on-site frack pump test cell software support.
Migrated the frack pump test cell control system to Windows 10 to address operating system end-of-life and maintain system reliability.
Developed a hardware abstraction layer (HAL) for a universal test set used for testing Class II ultrasound machines. The HAL was so robust that only one bug ticket was ever filed against it. It is still in use today. Non-product software verification and validation was performed in accordance with 21 CFR 820.70(i) to meet FDA quality system requirements.
Automated a friction loop system for driving fluid samples through compacted core samples to measure fluid viscosity and friction characteristics for the Production Engineering Chemistry R&D Lab's fracking chemistry development.
Designed and implemented building automation systems for a test cell building, automating scrubber and cooling stack with centralized monitoring and control of facility infrastructure.
Developed an internal website and database for all lab activities in a hydrocarbon production engineering chemistry R&D lab. The database addressed the critical need to get data well-formed in preparation for AI and advanced analytics initiatives.
Added test system capabilities to a large oil field services company.
Provided on-site troubleshooting and diagnostic support for test and production systems.
Performed Phase 1 verification and validation of a pulse neutron source tool in hardened bunkers with explosion shielding, designed for safety when working with high-energy neutron sources under immense pressures used in downhole well logging.
Executed Phase 2 V&V of the pulse neutron source tool, extending test coverage and completing validation activities in the hardened bunker test environment.
Developed monitoring capabilities for the pulse neutron bunker test configuration supporting downhole well logging tool validation.
Automated a rock permeability tester for characterizing how fluids flow through rock formations under controlled conditions, supporting the Production Engineering Chemistry R&D Lab's custom fracking chemistry development.
Automated sensor integration and data acquisition for test cell systems at the Carrollton facility.
Migrated test infrastructure software to Windows 10 to address operating system obsolescence.
Supported and upgraded the embedded control system for the client's flagship electronic fracking (E-frac) pump truck fleet.
Provided LabVIEW automation consulting services for the client, a global leader in audio and connected technologies. The engagement focused on test and measurement automation development.
Extended the data logging system with enhanced signal processing, expanded data channels, and improved playback fidelity for the novel EKG device characterization.
Completed the third phase of the data logging system with full verification and validation capabilities for the diagnostic EKG device.
Assembled and deployed five complete data logging and playback systems for parallel EKG device characterization and testing.
Developed the initial data logging and playback system for a novel EKG device employing wavelet and Fourier analysis to detect cardiac blockages and disease states in vivo. Work included reverse engineering the electrical schematic from Chinese to English after the PhD founder departed with no documentation.
Performed a gap analysis of the life cycle tester (LCT) HMI software for a Class III Active Implantable Medical Device (AIMD) LVAD manufacturer operating under an FDA warning letter. The engagement involved multiple reverse engineering assessments and development of requirements traceability matrices. Non-product software verification and validation was performed in accordance with 21 CFR 820.70(i) as part of FDA warning letter remediation.
Performed firmware gap analysis against FDA requirements for the Life Cycle Tester HMI software. Non-product software verification and validation was performed in accordance with 21 CFR 820.70(i).
Conducted a revision-level gap analysis to identify missing V&V documentation and compliance artifacts for the LCT. Non-product software verification and validation was performed in accordance with 21 CFR 820.70(i).
Reverse engineered and assessed software component SP00381 to establish requirements and traceability for V&V remediation. Non-product software verification and validation was performed in accordance with 21 CFR 820.70(i).
Reverse engineered and assessed software component SP00382 to document functionality and establish V&V traceability. Non-product software verification and validation was performed in accordance with 21 CFR 820.70(i).
Performed reverse engineering assessment of software component SP00397 for requirements recovery and gap remediation. Non-product software verification and validation was performed in accordance with 21 CFR 820.70(i).
Developed requirements traceability matrices linking requirements, design, tests, and results for the Life Cycle Tester V&V documentation. Non-product software verification and validation was performed in accordance with 21 CFR 820.70(i).
Delivered on-site V&V consulting and training for the Life Cycle Tester used in Class III LVAD implant life cycle testing. Non-product software verification and validation was performed in accordance with 21 CFR 820.70(i) as part of FDA warning letter remediation.
Developed a comprehensive LabVIEW coding standard ensuring consistent, maintainable, and compliant test software development for a Class III LVAD manufacturer.
Created a PDF reporting toolkit enabling automated generation of formatted test reports from LabVIEW test applications.
Provided emergency manufacturing support for an auto parts manufacturer.
Developed the initial website and online marketplace platform for curated book recommendations.
Developed the trading software for energy commodity market. Includes data storage, retrieval, and analysis.
Built energy management modules for the trading desk platform supporting Texas energy market operations.
Performed white-box testing for FPGA-based systems at the client. The engagement included non-product software verification and validation and system-level V&V, ensuring the FPGA firmware and associated software met medical device regulatory requirements. Non-product software verification and validation was performed in accordance with 21 CFR 820.70(i) to satisfy FDA quality system requirements.
Performed verification and validation of In Vitro Diagnostic (IVD) medical device for breast cancer screening. IEC 62304 software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.30 to satisfy FDA quality system requirements.
Provided technical consulting services for the client, supporting their engineering and product development needs.
Designed a new test set for a medical device. Demonstrated conclusively that the device itself failed to meet its own specifications, and had been falsely passing manufacturing tests for years. This redirected engineering efforts from test system redesign to product failure analysis. Test method verification and validation was performed in accordance with 21 CFR 820.72(a).
Performed rapid fixes of firmware and hardware for a consumer electronics company developing a precision IR thermometer with 0.1 degree Celsius accuracy. The FDA-cleared device predated COVID-19. The engagement addressed field failures threatening product reliability.
Redesigned verification tester V&V for test set for electromechanical endoscopic stapler. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i) to satisfy FDA quality system requirements.
Provided test engineering support for electromechanical stapler production test systems. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i) to satisfy FDA quality system requirements for medical device production.
Performed verification and validation of the closure force test system for endoscopic stapler subassembly testing. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i) to satisfy FDA quality system requirements for medical device production.
Developed test software for the endoscopic stapler product variant, extending the manufacturing ATE platform. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i) to satisfy FDA quality system requirements for medical device production.
Designed and developed the automated test equipment for production test of the handle of a multifunctional endoscopic stapler. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i) to satisfy FDA quality system requirements.
Redeveloped test software and performed verification and validation of test and measurement systems across the electromechanical stapler product line. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i) to satisfy FDA quality system requirements for medical device production.
Redeveloped the manufacturing ATE software to improve reliability and comply with updated quality requirements. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i) to satisfy FDA quality system requirements for medical device production.
Performed complete verification and validation of the automated test equipment for use in production of an endoscopic stapler shaft. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i) to satisfy FDA quality system requirements for Class II medical device production.
Provided V&V consulting services for additional ATE systems in the endoscopic stapler manufacturing supply chain. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i) to satisfy FDA quality system requirements for Class II medical device production.
Performed verification and validation test instrumentation OEM.
Flew to the client's headquarters in Penang, Malaysia to train a global team on FDA compliance, test method validation, and how to sell into the medical device and life science industries. The client flew in half of the global audience from the United States, underscoring the strategic importance of the engagement. Training covered non-product software verification and validation, test method verification and validation, 21 CFR 820.70(i), and 21 CFR Part 11 (electronic records and signatures) in the context of FDA quality system compliance.
Built a monitoring system for the client, an HVAC manufacturer. The system provided real-time monitoring and data acquisition for HVAC equipment performance, enabling predictive maintenance and quality assurance for their product line.
Developed a Kubernetes (k8s) deployment strategy for the client, focusing on containerized deployment architecture for aircraft subsystem applications. The whitepaper effort documented best practices and implementation recommendations for modernizing software deployment in aerospace environments.
Developed the LabVIEW-based Phase 1 hardware-in-the-loop test application for the shoulder-fired smart grenade guidance and control system.
Executed Phase 2 of the HIL test set development with expanded simulation capabilities and test coverage for the smart grenade program.
Performed software validation for the gantry-based production test system used in medical device manufacturing. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i).
Supported verification and validation of the multirun test station for medical device production line testing. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i).
Provided on-site installation labor support for PLC and SCADA system deployment on the Class II cosmetic implant packaging line.
Developed PLC programming for automated packaging line operations at a manufacturer of Class II cosmetic implants including breast, penile, and calf implants.
Configured and supported SCADA system for supervisory control and monitoring of the implant packaging line.
Converted legacy test applications to C++ to modernize the manufacturing test software infrastructure for one of the largest forklift manufacturers in the United States.
Developed firmware flash loader for loading firmware onto forklift trucks and managing configuration management during manufacturing.
Delivered LabVIEW training for medical device engineers. Training curricula included non-product software verification and validation, test method verification and validation, 21 CFR 820.70(i), and 21 CFR Part 11 (electronic records and signatures) compliance for FDA-regulated medical device quality systems.
Delivered LabVIEW training for semiconductor engineers.
Delivered training for Class III medical device engineers. Training curricula included non-product software verification and validation, test method verification and validation, 21 CFR 820.70(i), and 21 CFR Part 11 (electronic records and signatures) compliance for FDA-regulated medical device quality systems.
Taught LabVIEW Object-Oriented Programming (LVOOP) at NI Week conference.
Delivered LVOOP training for RF semiconductor engineers.
Delivered LabVIEW Core 1 & 2 training.
Delivered medical device V&V training in Toronto, Canada. Training curricula included non-product software verification and validation, test method verification and validation, 21 CFR 820.70(i), and 21 CFR Part 11 (electronic records and signatures) compliance for FDA-regulated medical device quality systems.
Delivered ULTARM medical device V&V training for a Fortune 500 medical device manufacturer. Training curricula included non-product software verification and validation, test method verification and validation, 21 CFR 820.70(i), and 21 CFR Part 11 (electronic records and signatures) compliance for FDA-regulated medical device quality systems.
Delivered medical device training for a Class III device manufacturer in Colorado. Training curricula included non-product software verification and validation, test method verification and validation, 21 CFR 820.70(i), and 21 CFR Part 11 (electronic records and signatures) compliance for FDA-regulated medical device quality systems.
Delivered medical device warning remediation training for a medical device manufacturer in Seattle. Training curricula included non-product software verification and validation, test method verification and validation, 21 CFR 820.70(i), and 21 CFR Part 11 (electronic records and signatures) compliance for FDA-regulated medical device quality systems.
Delivered LabVIEW Core 1 and TestStand training for a Class III device manufacturer in Colorado. Training curricula included non-product software verification and validation, test method verification and validation, 21 CFR 820.70(i), and 21 CFR Part 11 (electronic records and signatures) compliance for FDA-regulated medical device quality systems.
Delivered ULTARM training for a healthcare device manufacturer in Madison, Wisconsin. Training curricula included non-product software verification and validation, test method verification and validation, 21 CFR 820.70(i), and 21 CFR Part 11 (electronic records and signatures) compliance for FDA-regulated medical device quality systems.
Delivered FDA compliance training for a Fortune 500 medical device manufacturer. Training curricula included non-product software verification and validation, test method verification and validation, 21 CFR 820.70(i), and 21 CFR Part 11 (electronic records and signatures) compliance for FDA-regulated medical device quality systems.
Delivered medical device training in Colorado. Training curricula included non-product software verification and validation, test method verification and validation, 21 CFR 820.70(i), and 21 CFR Part 11 (electronic records and signatures) compliance for FDA-regulated medical device quality systems.
Presented LabVIEW Object-Oriented Programming (LVOOP) at NI Week conference.
Delivered LabVIEW Core 1 and TestStand training for a Fortune 500 medical device manufacturer in Arizona. Training curricula included non-product software verification and validation, test method verification and validation, 21 CFR 820.70(i), and 21 CFR Part 11 (electronic records and signatures) compliance for FDA-regulated medical device quality systems.
Delivered ULTARM training for electronic device manufacturers in Israel. Training curricula included non-product software verification and validation, test method verification and validation, 21 CFR 820.70(i), and 21 CFR Part 11 (electronic records and signatures) compliance for FDA-regulated medical device quality systems.
Delivered LabVIEW Core 1 & 2 training for a Class III LVAD manufacturer. Training curricula included non-product software verification and validation, test method verification and validation, 21 CFR 820.70(i), and 21 CFR Part 11 (electronic records and signatures) compliance for FDA-regulated medical device quality systems.
Updated laboratory test software for oilfield equipment characterization and validation.
Provided ongoing support and maintenance for the client's laboratory software systems.
Developed pump test stand software for characterizing and validating oilfield pumping equipment performance.
Traveled to Tel Aviv, Israel to help an electronic cigarette (ENDS) company understand and meet US FDA medical device regulations. Consulting included guidance on 21 CFR Part 11 (electronic records and signatures) and non-product software verification and validation requirements under FDA quality system regulations.
Integrated Fluke instrumentation into the GPS device test infrastructure.
Developed software for laser etcher integration in GPS device manufacturing and serialization.
Built a multi-tool test wizard for streamlined GPS device test execution.
Developed a multi-tool test system consolidating multiple test functions for GPS device manufacturing.
Designed and built the test fixture for GPS device functional testing.
Developed the test jig for mechanical alignment and electrical connection during GPS device testing.
Developed test capabilities aligned with certification requirements for GPS devices intended for hazardous environments.
Developed test capabilities aligned with FEMA certification requirements for GPS emergency communication devices.
Developed test software for GPS device.
Built JTAG programming interface for GPS device firmware loading and debug.
Developed shelf-out test procedures for GPS device final inspection before shipping.
Developed USB interface and laser etcher control software for GPS device serialization.
Provided RF board design and integration to fleet management SaaS company.
Provided mechanical engineering and design services for the client, a California-based company manufacturing smokestack emissions monitoring systems. The project supported development of precision environmental monitoring equipment for regulatory compliance.
Modernized the CI/CD pipeline at the client by updating the continuous integration and continuous deployment infrastructure for test software build and deployment automation.
Completed a focused development project for the client supporting their RF device testing and characterization infrastructure.
Developed the core BAW (Bulk Acoustic Wave) filter wafer probe test software achieving 150-millisecond cycle time with 70ms acquisition and 80ms post-processing during prober indexing.
Developed an intelligent S-parameter file converter that monitors a folder, auto-discovers data files, dynamically determines file type, parses data, and converts into common units and format for RF modeling database ingestion. Fully automating S-parameter RF modeling ETL flows long before AI was cool.
Extended the S-parameter converter with additional file format support and improved conversion accuracy for RF modeling workflows.
Built a standalone S-parameter conversion application for batch processing of data files across multiple RF measurement formats.
Updated production test software for the second-generation cardiac support device -- a Class III device that holds the heart during open-heart surgery, cools it, and pumps blood through the body to maintain circulation. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i).
Designed and developed new test software for the third-generation cardiac support device production testing. Non-product software verification and validation and test method verification and validation were performed in accordance with 21 CFR 820.70(i).
Ported LabVIEW algorithms to CUDA for GPU computing acceleration, an early application of GPU parallel processing predating the widespread adoption of GPU computing driven by AI and cryptocurrency.
Developed Modbus protocol communication software for industrial test system integration.
Developed a test system leveraging industrial communication protocols.
Supported a pick-the-light table system guiding operators through manufacturing assembly sequences to reduce assembly errors and improve production efficiency.
Performed rapid firmware and hardware fixes for the client, a consumer electronics company facing field returns on their iPad keyboard product that threatened a major retail account with a consumer electronics maker known for exacting standards. The urgent engagement diagnosed and resolved embedded system failures, essentially saving the company from potential financial crisis. The relationship has continued from 2023 through present day, with our team called in multiple times to resolve urgent field issues.
Developed a manufacturing test set for the client, a global electronics manufacturing services provider. The system incorporated motion control and supported automated manufacturing test operations requiring precision positioning.
Performed operating system migration for critical test equipment at the client, migrating to a modern operating system and then revalidating the test set to ensure it still met specifications. The migration ensured continued operation of essential test and measurement systems following OS end-of-life, maintaining data integrity and system reliability for ongoing oil and gas operations.
Developed LabVIEW test software, a hardware abstraction layer, and camera-based test system for the client, a manufacturer of automotive ignition interlock devices (court-ordered breathalyzer systems for DUI offenders). The test set validated the interlock device functionality including breath alcohol detection, vehicle interface communication, and tamper detection.
Designed the GUI and performed verification and validation for a Class II post-surgical treatment device that uses electromagnetic fields to induce eddy currents on the surface of hip, knee, and shoulder implants to kill bacterial biofilm at the implant boundary, addressing the number one complication of implant surgery (1 in 10 patients). Non-product software verification and validation was performed in accordance with 21 CFR 820.70(i).
Developed RTOS (Real-Time Operating System) software for a sensor package that detects pipeline breaches and occlusions for the client. This proof-of-concept project for the startup demonstrated the feasibility of real-time acoustic and pressure monitoring for pipeline integrity assessment in oil and gas infrastructure.
Provided test engineering consulting services for the client, a leading medical device manufacturer. The engagement supported the client's test and measurement infrastructure for medical device production and quality assurance.
Developed initial manufacturing test capabilities for optoelectronic semiconductor production testing.
Provided software consulting for test system architecture and development strategy for optoelectronic devices.
Built automated test capabilities for optoelectronic device quality validation.
Developed motion control systems for the client, supporting precision electrical discharge machining operations with automated motion control and positioning systems.
Developed a replacement for an end-of-life firmware flashing device. Reverse engineered the legacy programmer and delivered the hardware fixture, hardware interface, and a software API for integration with the client's manufacturing execution system (MES).
Provided QA laboratory software support for HVAC electronic control modules.
Provided quality assurance laboratory support maintaining and enhancing test and measurement software for HVAC product validation.
Supported manufacturing test and automation systems for HVAC enclosure production.
Supported manufacturing test and automation systems for HVAC enclosure production.
Reverse engineered an ultrasonic solder pot for air conditioner assembly process, with emphasis on de-risking the manufacturing line and maintaining backwards compatibility.
Performed AI language model analysis to support a UK-based custom translation company providing document translation and validation for immigrants entering the UK to establish provenance of identity and citizenship.
Developed a minimally viable Quality Management System (QMS) and design history file for University of Texas researchers seeking to commercialize early-stage medical device research. The engagement provided the regulatory framework needed to translate laboratory innovations into fundable medical device development programs.
Designed and built the initial pivot fixture for verification and validation of robotic surgical arm components for a robotic surgical assistant.
Developed pivot fixture with enhanced measurement capabilities for robotic surgical subsystem testing.
Developed dynamometer test capabilities for characterizing downhole reservoir analysis tool mechanical performance.
Built bench top test application for laboratory characterization of reservoir analysis tool components.
Developed a hardware abstraction layer for manufacturing test systems supporting the reservoir analysis tool string production.
Built a characterization system for a quantitative reservoir fluid analysis system.
Developed manufacturing production test set of reservoir analysis tools.
Provided troubleshooting services for the client, diagnosing and resolving technical issues in their test or production systems.
Developed a proof of concept for a TestStand-based test executive framework.
Provided system architecture and mechanical/electrical engineering scoping for the client, an implantable pulse generator (IPG) startup. The engagement defined the technical architecture for a medical robotic nerve stimulation system, establishing requirements and feasibility for the device development program.