Lucas Holt

About Lucas Holt

Director of Systems Engineer - BrightInsightMedical Device Research Founder - Javelin Devices Inc.(Independant Researcher - UT Austin Lecturer)Experienced System Engineer with a 15+ year history of working in the medical device industry. Skilled in Digital Signal Processing, Embedded System Design, Matlab, C/C++, Analog Hardware, PCB Design, Biomedical Instrumentation, and Microprocessors. Deep understanding of regulated medical device development including Risk Management (ISO 14971), Quality Management Systems (ISO 13485), Software Development Lifecycle (IEC 62304), and Medical Electrical Equipment (IEC 60601) Holds a PhD in Electrical Engineering from The University of Texas at Austin with a focus in Embedded Biomedical Instrumentation, Digital Signal Processing, and Cardiac Electrophysiology.

Experience

1. Director - Systems Engineering

   Brightinsight

   Apr 2022 — Present · Austin, TX, US

   Leadership• Managed a team of five Systems Engineers, overseeing project delivery and fostering professional development.Process Excellence• Spearheaded the standardization of core Systems Engineering processes, including:• Developing system architecture, defining requirements, and managing requirements decomposition.• Implementing cybersecurity risk analysis (AAMI TIR57, NIST 80•••••12) and top-down hazard analysis.• Managing QMS and defining SOPs for compliance with ISO 13485, IEC 62304, and ISO 14971.• Introducing a Privacy by Design process and standardizing platform decomposition and interface.• Served as the Organizational Administrator for the JAMA Application Lifecycle Management (ALM) tool.Key Project Delivery• Oversight of System Engineering role for delivery of key mobile applications for enterprise clients:• Tresiba (Dose Check) for basal insulin titration.• Dupixent MyWay for tracking patient injections.• Roche: My Vision Track for Metamorphopsia Syndrome vision testing.

Education

• The University of Texas at Austin

  Master of Science (M.S.), Electrical Engineering

  2013 — 2014

• The University of Texas at Austin

  Bachelor of Science (B.S.), Electrical and Computer Engineering

  2009 — 2012

• The University of Texas at Austin

  Doctor of Philosophy (Ph.D.), Electrical Engineering

  2014 — 2017

Skills

• Fpga
• Embedded Software
• Electronics
• Cardiac Electrophysiology
• Java
• Pcb Design
• Biomedical Engineering
• Iec 62304
• Microprocessors
• Matlab
• C++
• Swift
• Machine Learning
• Iec 60601
• Ble
• C
• Programming
• Software Development
• Debugging
• Labview
• Hardware
• Digital Signal Processing
• Systems Engineering
• Systems Design
• Circuit Design
• Embedded C
• Firmware
• Embedded Systems
• System on a Chip (Soc)
• Vhdl
• Simulations
• Radio Frequency (Rf)
• Real-Time Operating Systems (Rtos)
• Ios
• Electrical Engineering