Donald W Yeh

EXPERIENCE SUMMARY

Years of work experience in system architecture, integration, design, development and testing.

Extensive engineering experience in medical and semiconductor equipment industry.

Experience in defining, developing and integration both real time embedded and PC applications software with other components. (electrical, mechanical, optical)

TECHNICAL SUMMARY

Familiar with software development standards, procedures and management.

Understand and familiar with SDLC, ISO, FDA regulations for 510k submissions.

Experience with Windows, UNIX, Linux, QNX, Qt, VxWorks, WinCE, MicroC/OS-II, C/C++, Git, C#.NET, Python, UML, Enterprise Architecture, ClearCase, OOP, DOORS, Agile Process, and TDD.

Experience working with ARM Cortex-M3, TM4C129x Cortex-M4, PIC32, ColdFire, Renesas H8SX/1544 micro controllers.

EDUCATION

B. S. in Computer Engineering, University of Michigan, Ann Arbor, MI

PROFESSIONAL EXPERIENCE

Amgen Inc., Thousand Oaks, CA 2018

Sr. Device Software Engineer (Consulting)

Participate in firmware and process development for combination products.

Architect/design system software components for combination products platforms.

Authoring software documentation, implementing software, test, integration, and formal verification. STM ARM; C/C++; C; IAR

Follow a disciplined product development process and participate in technical reviews and ensure robust deliverables and documentation traceability.

Pulse Biosciences Inc., Hayward, CA 2016 – 2017

Sr. Software Engineer

Designed and developed UI for Pulse Generator using Visual Studio 2015 (C# .Net).

Led a Labview consultant to designed and developed embedded pulse generator medical device system which includes creating the time/resource estimation effort, regular updating of status in a project schedule and technical guidance. LabView, LabView/CVI; PIC32; UART.

Wrote technical protocols/reports and other design control documentation such like Software Hazard Analysis, Software Requirement Specification, Software Design Description and Software Test Protocols and Test Reports in support of regulatory 510K FDA submissions.

Interface with Quality, Regulatory, Marketing and Project Management.

Cerus Corp. Concord, CA 2015 – 2016

Sr. Software Architect

Designed and developed embedded INTERCEPT Blood System which enable the use of pathogen reduction technology (PRT) as an option, in place of certain tests and/or procedures to address residual TTI risk including bacterial contamination, Zika virus, and transfusion-associated graft vs host disease (TA-GVHD). QNX6.0

Prototyped GUI for next generation INTERCEPT system (Visual Studio 2013, C# .Net).

Wrote technical protocols/reports and other design control documentation such like Software Hazard Analysis, Software Requirement Specification, Software Architecture Document, Software Design Description and Software Test Protocols and Test Reports in support of regulatory 510K FDA submissions.

Flex (Nextracker), Milpitas, CA 2014 – 2015

Sr. Firmware Engineer

Architecture Nextracker controller system, design & development: interfacing with cross functional departments to meet program objectives and milestones. TM4C129x Cortex-M4, board bring up, ADC, PWM, FreeRTOS, ZigBee, CCS, GIT.

C# .Net; WCF, State Chart, Factory, Façade, UML, TCP/IP networking, socket programming; developing system database to collect data and analysis; design and developing manufacturing configuration tool to calibration and performance testing; wireless software upgrade. Developed unit test software using Python.

Medtronic Inc., Mountain View, CA 2013 - 2014

Firmware Architect

Working with outsource, debug and enhance existing embedded software. ARM Cortex-M3, PIC32; Qt, Embedded Linux.

Created and review technical document such like Software Architecture Document; Software Hazard Analysis, Software Requirement Specification, and Software Test Protocols and Test Reports in support of regulatory 510K FDA submissions.

Developed test software using VS/WPF for managing data and data analysis.

Solta Medical Inc., Hayward, CA 2011 – 2013

Software Architect/Principle Software Engineer

Architectures design and developed next generation RF system for medical aesthetics device (Class II); the system has Windows 7 embedded as host with 7 embedded controllers running on MicroC/OS-II RTOS. (EA, UML, OOA, OOD). medical aesthetics

Designed and developed new features for existing laser medical aesthetics device.

Windows C/C++/C#.Net/Assembly, Green Hill Integrity; QNX, STM Cortex-M3, IAR, CAN, ADC, RS232, TDD.

Tronics Medtech, Inc., Sunnyvale, CA 2008 - 2011

Director of Software Development

Led and team, architecture and designed New Robotic Systems for lab automation. This bench-top instrument brings speed, reliability and cost-efficiency to the laboratory liquid handling. The system is developed based on Renesas H8SX/1544 microcontroller with in house RTOS. I developed whole system including CAN bus driver, RS232 driver, integrated WIZnet Ethernet (TCP/IP & UDP) driver and SPI driver for NVM; C#.Net. EtherCat Communications.

Architectures and developed RAB implantable Obesity Management Control using WindowCE, MPLAB, Salvo OS, PIC18, Wireless (Chipcon CC1101).

Terumo Medical Inc., Fremont, CA 2003 - 2008

Firmware/Software Engineer

Responsible for design, developing and integration medical device instruments for the healthcare industry

Designed and developed the human blood separation products. The embedded device has three micro controllers (ARM& ColdFire): touch screen GUI controller, Main and Safety controllers. It has embedded motion, sensor, and pump controllers.

Developed Exhaled Nitric Oxide (eNO) monitor system (asthma management): a highly accurate device, expressly designed for the physician’s office. Cold Fire, DSP, Linux, Qt.

Designed and developed insulin pumps embedded system for continuous insulin delivery medical device. The system has two ARM microprocessors – one for main UI controller and the other for motor controller (ThreadX, IAR, ARM9, UML, C#.Net), Agile, TDD.

Carl Zeiss Meditec, Dublin, CA 2000 - 2003

Staff Software/Firmware Engineer

Responsible for designing and developing software/firmware to provide products for the eye care profession with instrumentation to enhance the quality of patient care, increase practice efficiency, and improve diagnostic capabilities in a team environment.

Designed and developed the WaveFront controller system for refractive surgery patients. The WaveFront system is Motorola H16Z1 based running on multi-tasking operating system. The system has five-step motors, the camera controller, and image processing; C#.Net; Java.

Novellus Systems, Inc., San Jose, CA 1996 - 2000

Sr. Software Engineer

Responsible for designing and developing software/firmware for semiconductor capital equipments.

Designed and developed the Novellus CVD machine control systems (a distribute controller systems). Window NT; VC++ 6, MFC; QNX2/4 and developed using C/C++.

Silicon Valley Group, Inc., San Jose, CA 1993 - 1996

Software Manager

Responsible for managing and developing software/firmware for semiconductor capital equipments.

Managed software department to support 9x track system software. Defined and assigned software projects, interface with other departments and customers, hiring software engineers and did software engineer performance review for the department.

Raynet Corporation, Menlo Park, CA 1990 - 1993

Senior Software/Firmware Engineer

Responsible for design and developing software/firmware for fiber communication systems.

Designed and developed Special Service Interface Card firmware to accommodate existing out-of-house special T1 compatible service line cards. 8051-based processor supports provision cross-connects to special service line cards, does maintenance support, diagnostic testing, alarms processing and debugging monitor. Sun UNIX workstations.

Varian Medical Inc., Palo Alto, CA 1983 - 1990

Senior Software/Firmware Engineer

Responsible for design and developing software/firmware for linear accelerators control systems.

Led team to analyze, design and implement a large scale integrated real-time radiography imaging system. The system use high-energy x-ray to capture image and use software-enhancing image by histogram, edge enhancement, shaping, neighborhood averaging and pseudo-color processing.

Responsible for design and developing software/firmware for linear accelerators control systems for oncology care systems.

Siemens Medical Systems, Inc., Concord, CA 1992 - 1996

Senior Software Engineer (Part Time)

Responsible for software/firmware testing and verifications for oncology care systems.

Guided a test team by providing technical leadership, developing effective schedules, and coordinating test team tasks for the test plan, test case design and test reporting.

Provided status of significant testing and quality issues to the program manager and management during product development cycle. Executed software validation and verifications for medical controller system to meeting FDA requirements.

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