Name: Yashwant Shitoot
Address: Santa Clara, CA 95050
Objective: Working on Medical Device Software/Firmware.
Extensive experience in software development. Over the years in all
aspects of software projects.
Excellent written and verbal communications skills.
Co-instructor for ASQ Biomedical Class #633 – “Design Verification
and Validation”. (No longer teaching this course.)
Very good people skills. Easy to get along with. Able to develop
relationship even with difficult to get along with people.
About twelve years working in Medical device industry. Have a very
good understanding of FDA requirements for software development
and related documentation. Have completed a course in medical device
software Verification and Validation
Extensive experience in all aspects of software quality. Writing test
plans. Code Reviews. Unit Testing. Regression Testing. Automation of
testing. Building in software quality.
Participated in Hazard Analysis. Wrote Software Requirements
Specifications, Software Design Documents. And Protocols for
Software Verification and Validation.
Experience in software Architecture on 10+ projects. (distributed over
various employers over the years). Also experience in creating
Software Requirements Specifications and Software Design
Interfacing and managing customers. Understanding and meeting
expectations of higher management.(At Stellartech, Eyring, and during
10+ years of consulting).
Software Process Improvement to enhance productivity of software
group. (see Stellartech below).
Interfacing with motors for controlling motion.
Very good understanding of software development process. Including
all phases of SDLC.
Excellent working knowledge of FDA Part 820, ISO 13485 and IEC
“C”(15+years), Several Assemblers(10+years), C++.(4 years) To lesser
extent Basic, Pascal, Fortran, Forth.
Windows, Linux, uC/OS, VxWorks and other embedded Operating
Networking Drivers, TCP/IP, UDP
Master of Science in Physics.
Consulting Client: Jan. 12 – Jun. 12 Stellartech Research Corp. Sunnyvale CA.
Software Design Documentation.
Software Verification Protocol.
Writing test Software.
Lumasense Inc. , Santa Clara CA. Sept. 2010–May 2011 (Employee)
Sr. Embedded Engineer: (Not a medical device company)
Started out with software – mostly maintainance. Later moved to doing
hardware design and development.
Software Consultant. Sept. 2008 – Sept. 2010
Teaching: American Society for Quality
Instructor for a class on medical device V&V (together with Aaron
Joseph). (Discontinued - this course discontinued.)
Consulting Client: Aragon Surgical, Palo Alto CA.
Solving really difficult i2c communications problem.
Adding features to and fixing bugs in their surgical sealing software.
Redesigning software to make it well structured, modular and easy to
Consulting Client: Tronics - MedTech , 1296 Lawrence Station Rd.
Sunnyvale CA 94089.
Firmware Development (TI's MSP430, IAR C/C++).
All SQA functions. Planning, Testing, Risk Analysis.
All Software related documents needed for FDA. From Software
Development SOP to test Protocols.
Consulting Client: Advanced Medical Optics, 510 Cottonwood Dr. Milpitas CA
Wrote Risk Management Plan and Software V&V plan for a new
Discovered an algorithm bug. Conducted full analysis and wrote report.
8x8 Inc., Santa Clara CA. Feb. 2007 – May 2008 (Employee)
Firmware Engineer: VOIP.
Wrote Wireshark add-on for proprietary NAT proxy server.
Optimized the NAT proxy server code for speed.
Integrated third party TLS/SSL software with in house code for secure
communication over network.
Implemented voice quality matrices reporting.
Stellartech Research Corp. , Sunnyvale CA. Sept. 2001–Nov 2006
Sr. Software Engineer/Project Manager: Medical Electronics.
Completed a couple of projects to cut using RF energy requiring
controlled sparking. And then to extract the tissue sample and robotic
control of catch and extract mechanism.
Took initiative to suggest and then implement a script driven,
automated test program for embedded GUI in embedded Linux
environment. This program was also used to debug both GUI and Real
Time portions of the application.
Took major initiative for long term improvements in software quality
and software development process. This resulted in me teaching a class
at Stellartech in Software Process Improvement.
To facilitate development of software, when hardware is also in
development stage. Wrote a simulation program to simulate critical
parts of hardware. This program turned out to be more useful than
initial expectation because it allowed software to be tested under error
conditions which can not be easily created. Also when debugging
hardware, this gave a higher degree of confidence in software.
Developed/Completed a MIPS/Embedded Linux based handheld device
project to collect 24 hours of medical data on study patients.
Developed/Completed several Radio Frequency generator projects for
different medical uses. Couple of the projects also involved electro-
mechanical system for controlling the motion of a biopsy sample cut
and extract device.
Software Consultant , Salt Lake City UT. April 1999 – Sept 2001 and from
1984 through Oct 1994. Full time job from Oct. 1994 through April 1999.
During this period major clients/jobs were:
Acuity Research, Atherton CA. (May 2001 -Sept. 2001)
Worked on laser based distance measuring system using ARM
processor Greenhill’s development environment and Thread-X
operating system. (NetSilicon board) Mostly in “C” or assembler.
STSN (Salt Lake City UT April 2000-Dec. 2000)
Wrote Enhanced Network Driver (VxWorks END driver) for USB.
Also developed NDIS/USB driver for Windows 2000/98. Worked on
networking protocols, Telnet and FTP servers. Most of this work was
Vinca/Legato Systems Inc, Orem UT. April 1999-April 2000. (Employee)
Worked on writing kernel level device drivers to port Vinca’s patented
“Snapshot” product to SAN device from Crossroad, a VxWorks based
system. Also kernel level device drivers on Linux to port “Snapshot” to
Linux based system. Mostly in “C”.
Fonix Corporation, Salt Lake City UT. Nov. 1996-Jan. 1999 Research
Scientist and Software Engineer. (Employee)
Worked in the overall field of Speech Recognition.
Studying and solving problems in speech recognition by development
of new algorithms and/or using Neural Networks.
The research work has generated material for four patent applications.
This work included writing code in C as well as in Matlab.
Eyring Corporation, Salt Lake City UT. March 1995-Nov. 1996
Product Development Manager for PDOS:
Designing and implementing a new Real-Time Multi-Tasking
Maintenance/Enhancements for Real-Time Multi-Tasking operating
system for 68xxx VMEbus boards (PDOS).
Interfacing with customers and potential customers.
Dynatek Video Group (Salt Lake City UT 1993-1994)
Software for Text and Graphics System (TAGS) a TMS 320 (dual core)
based video display system.
Wrote Real-Time OS for dual core SMP. Wrote interrupt handlers, user
interface and driver for video display.
COLMEK Systems Engineering, Salt Lake City UT. 1984 – 1994 ON and
Software Development Leader for their Video Enhanced Sonar Display
systems (VESD). This has been a major product line for COLMEK
systems. VESD is a 68xxx based system used to display sonar data on
screen. About 90% of the software was in assembly language.
Wrote Video BIOS, device drivers for various peripherals (DMA,
Serial and parallel communications CRT controller, A/D converter,
Wrote software for Digital Image Processing on some versions of
VESD. This was designed for the purpose of edge detection, frequency
detection through FFT and manipulation of the image.
Developed Data Communications Software for equipment used for
finding the TITANIC.
Promontory Systems Inc. Salt Lake City UT. Dec. 1990 - July 1992
Developed device drivers for a CalComp digitizing pad (WIZ) to act as
a mouse under MS-DOS, Windows and OS/2. (x86 Assembler).
Certifications : .
Medical Devices software verification and validation Certification (a 10
Education : Bachelor of Science Indore University, Indore India
Master of Science in Physics. Auburn University, Auburn Alabama
References: Furnished upon request.