As the software manager for this STARTUP medical device manufacturer company, my roles included:• Led a team of engineers.• Developed complete firmware stack for ARM-Cortex M processor (STM32H and STM32F) families.• Integrated FreeRTOS into both processors.• Interactive GUI development using TouchGFX library.• Communication device driver development for I2C, SPI, UART, CAN and 1-Wire.• Memory management drivers for external SDRAM and FLASH chips.• Bootloader implementation through CAN bus.• File management using SD Card and USB device for logging and file exporting.• Designed and released the software development process to meeting FDA 62304 compliance for a class 3 medical device.• Created requirements, hazard analysis, development plan and testing plan. Notable achievement's:• Full functional prototype created and released to formal testing.• Implementation of software development practices using JIRA and Confluence.• Compliant software development system released into the corporate quality management system.

As a principal engineer for this STARTUP medical device manufacturer company, my main role was to lead the firmware development of a real-time RNA/DNA molecular diagnostic system using CRIPSR technology.The embedded design focused on an ARM-Cortex M processor (STM32H family) with the following designed features:• Embedded GUI development using TouchGFX library supporting a touch interface.• Device driver development for I2C, SPI, UART, External EEPROM, RAM and FLASH devices, various stepper/DC motors and external multiplex devices.• Network drivers for hospital communication via RS485.• Wireless communication using WIFINotable achievement's:• Working prototype developed within 6 months.

As a software lead, my role was to design and develop firmware for a real-time molecular diagnostic device using several ARM core processors (STM32F family). Promoted to Director to support global launch. My major managerial duties encompassed:• Building up local team to support product during development and launch.• Perform performance reviews, handle software department budget, and interface to customer and external suppliers as needed.• Provide software support for Manufacturing / Service and Field Apps (tool development).• Led software quality assurance / FDA audit point of contact for software development.• Designed firmware architect.Day to day tasks include:• Implemented software quality process that complies with IEC62304 for a class 3 medical product. Documentation included requirements, hazard analysis, traceability, unit test protocols, integration test protocols and architecture design documents.• Designed embedded code in C/C++ for controlling motors, optical fluorescent measurements, reading/writing external EEPROM’s, controlling Analog to Digital IC’s, PWM controlled temperature and DMA for faster throughput• Designed system for extremely fast through-put using FREE-RTOS to filter, average, process and interpolate hundreds of temperature/current and voltage readings per second. • Low Level protocols developed: SPI, I2C, UART, CAN, 1-Wire and USB.• Developed common bootloader for all products within NeuMoDx Molecular.• Developed Python scripts for post run analysis, data mining and tool support.• Implemented software design with UML notation using Enterprise Architect.• Designed .NET applications used in manufacturing, service and field application for auto tester, auto calibration and general diagnosticsNotable achievement's:• Successfully launched multiple products into the field from the ground up.

As Director of Special Software projects for medical STARTUP company, I designed several prototypes for an ECP (External CounterPulsation) product that aided in blood circulation while staying in synchronization with the heartbeat. Product was written in embedded C and used technologies such as custom PID control, UART, CAN, I2C, USB and flash file system. Embedded design was completed on 2 different processors; PIC16 for slave board and Renesas RL7 for motherboard. Designed basic user end GUI to show graphical results using Visual Studio 2012.Design also consisted of creating and maintaining a manufacturing end of line tool for automated testing and serialization through a SQL database. In addition, I designed an automated test fixture to allow for 24/7 testing of the device through user defined script files.As software director, my duties also included:• Build from ground up a local team to support product during initial development phases.• Setup software quality system to comply with FDA standards for a class 3 medical device.• Setup software development group framework with tools such as issue tracking tool, source repository, and requirements management.In addition to the design, I implemented the software process to meet the IEC62304 guideline for software development. Design documents were created using DOXYGEN and enterprise architect. Product was a Class B level.The following guidelines were used:IEC 62304, IEC 60601ISO26262, ISO14971Medical Device Guidelines

As a consultant, my role was to work with the software engineers in designing the software process system to comply with CMM level 2i. Developed and defined the tools and methods needed to achieve that level. Major focus was on testing (unit level, integration and system testing) and tracing those tests to requirements, design documents and architecture level documents. Extensive experience with VectorCAST for unit level testing and traceability.In addition to software process managing, I worked at the code level in designing specific unit level software modules for OEM air bag deployment modules. Design was done using UML for documenting and Stateflow/Simulink for modeling. Code was developed using ANSI C on an Infineon 32-bit processor.

As chief engineer, my responsibility involved managing up to 12 software engineers who worked on blood monitoring and data collection systems. My major role was to lead the software design and development for these products under the FDA guidelines for IEC62304. Other major duties included design of SW architecture, leading SW hazard analysis design, involvement in extensive code reviews, code audits and unit testing, creation of SW requirements, creation of traceability matrices, full life cycle development from concept phase through formal verification and participating in audits against the SW development process both from external auditors and internal auditors. The blood monitor software product consisted of a multi-micro design with “plug-n-play” type of technology to support external custom modules and allow for future expansion. The main module was developed using Windows XP Embedded and Visual C++ on an Intel Pentium 4 Processor off the shelf POC terminal. Custom external units were designed using Hitachi 16-bit processors as well as Microchip PIC12 devices. Communication link was developed using a mixture of I2C and serial RS232 communications. In addition to the embedded design, I led the software development on the Windows platform which consisted of object oriented based design and concepts, graphics that utilized Microsoft DirectX for 2D plotting, Microsoft DirectX input for external input control and the WIN32 structure for the operating system.The data management system was designed on an Intel Pentium 4 Processor off the shelf point of care terminal using a combination of Visual C++ and C#. It used a MYSQL interface to store patient records and information and allowed for 2D graphing and plotting of selected data. The product communicated with external devices such as heart lung machines, pumps, monitors, etc. through an RS232 communication. Data was accumulated and stored within the data management system until post processing was required.

Lead software designer on body module computer that receives, decodes and decrypts RF data from key fobs and tire pressure sensors. Code modules written include raw RF data receive, filter, and noise rejection software, low speed CAN driver, off board EEPROM driver, basic I/O driver layer for analog and digital signal processing, SPI driver for external test tool requirements and UART handler for PC interfacing. All low level drivers written in PIC and NEC assembly language. High level application written in ANSI C. Successfully launched product into production in 2007.Further software design consisted of diagnostic applications created using Visual Basic and Visual C++ 6.0 as well as automated bench test windows based applications to ensure proper software design. Real time data acquisition software created to support in-vehicle drives. In addition to code design, my roles include customer presentations, requirements analysis, specification writing, architecture design and debugging code. Microcontrollers used NEC 78F0889 (K0) / 78F922 (K0S) and PIC12F683 / PIC16F684 / PIC16F688.Lead software engineer on tire pressure monitoring and remote keyless entry application development. Designed and coded RF receiver which included, raw RF receive and decode routines, EEPROM drivers, UART communications, CAN drivers / Bootloader, Dual microcontroller communications and in vehicle flashing. Also developed test scripts and in vehicle development programs written in Visual C++, Perl and MySQL. Microcontrollers used PIC16F627/28/28A and Motorola S12DG128.