SW System Validation and Verification Engineer, Medical Device
Resume:
Evelyn J. Noonan
P.O Box ******
Los Gatos, CA. *5032
***@**************.***
EDUCATION: B.T. Technical Computing, with a Math Minor, Washington University,
St. Louis, Missouri, 1992
EMPLOYMENT HISTORY:
Present: TBear Treasures, Campbell, CA
Owner
05/11 to Lutronics, Milpita, CA
11/11 Technical Lead Senior Systems Software/Hardware Engineer - Verification and
Validation
Led a small team of testers to complete V&V testing on a new Class 3 laser
system. Design and executed new test plan and cases for new system for the
GUI interface and controller software/hardware. Created Traceability Matrix for
system. Used Bugzilla to track bugs found during V&V testing.
Environment:Windows CE, Bugzilla, C, Logic Analyzer
08/10 to Spinal Modulation, Menlo Park, CA
02/11 Senior Software Engineer - Verification and Validation
Verification and validation of embedded firmware on a Class 3 surgically
implantable neurostimulator for treating chronic pain patients. Created unit test plan
and specifically created V&V tests for the Pulse Generator Module, which was
the part of the medical device generating RF frequency used for treating pain. Helped
with feedback in development of software tool which does verification of RF
frequency waveforms and behavior, and used said tool for verification purposes.
Generated V&V documentation used in formal testing, as well as traceability
matrix for the overall system (all modules).
Involved with software formal code reviews for PGE module, and entering
bugs into database when found. Environment: Windows XP, Cygwin, TCL, SVN,
IAR Visual State, TI MSP 430, Logic Analyzer
08/09 to Lumenis, Santa Clara, CA
06/10 Technical Lead Systems Verification and Validation Engineer
Led a small team of testers to complete V&V testing on a Class 3 laser system. Design
and executed test plan and cases for new features to the GUI interface, FPGA and
controller software and hardware. Maintained Traceability Matrix for new features added
and involved in Hazard Analysis review as well as formal code review. Used Bugzilla to
track bugs found during V&V testing. Main contact with QA and document control to
submit document changes and final test documents with test reports. Environment:
Windows CE, Bugzilla, C++, Logic Analyzer
10/08 to Nevro Corporation, Palo Alto, CA
12/08 Senior Software Engineer Consultant
Debugged and coded Python script to upload and create Diagnostics report from data
downloaded from a Medical handheld device written in C++. Environment: Python
2.5.2, Object-Oriented, Windows XP and Vista
08/06 to Pathwork Diagnostics, Sunnyvale, CA
01/08 Senior Software Engineer
Provided consulting on Diagnostic software with viewpoint to FDA requirements.
Created Software Requirement Specification and Software Design Specification
documentation for medical diagnostic software as well as Independent Software
Safety Analysis. Work on Verification/Validation of Software related to web-based
Diagnostic software for site of cancer tumor. Created Test Protocols/Reports for
Verification/Validation of Diagnostic software ran on a JAVA platform with
Affymetrix 3000 scanner genechip interface. Used software tools to create
documentation (Visio, OmniGraffle, Powerpoint, Word, Excel), C++ environment
04/06 to Cierra, Inc., Redwood City, CA
11/07 Senior Software Engineer
Created Software Requirement Specification and Software Design Specification
documentation for medical device software. Independent Software Safety Analysis
and Verification/Validation of Firmware related to a RF Generator and of Software
User GUI Application. Created & ran Test Protocols/Reports for
Verification/Validation of RF Generator and User Application, both black and white
box testing. Used software tools to create documentation (Visio, OmniGraffle,
Powerpoint, Word, Excel), C#/C environment
07/04 to Emtek Group, Hayward, CA
11/04 Senior Software Engineer Consultant
Independent Software Safety Analysis and Verification/Validation of Software
Safety related to nuclear systems.
09/03 to SECA Engineering, Carson City, NV
12/03 Senior Software Engineer Consultant
Worked on algorithms pertaining to the Aerospace Industry in simulation
software. Environment: COMPAQ Visual FORTRAN 6.1
07/03 to Sierra Engineering, Sacramento, CA
12/03 Senior Software Engineer Consultant
Worked on algorithms pertaining to the Aerospace Industry in simulation
software. Environment: COMPAQ Visual FORTRAN 6.1
10/01 to GE Nuclear, San Jose, CA
08/02 Senior Software Engineer Consultant
Worked on safety systems chassis for various safety related functionality.
New code development with prototype custom built hardware which processed signals
coming in from nuclear reactor to determine if safety state is being maintained by
nuclear power station. Wrote documentation required by the industry, including SDS
documentation, communication protocols, etc. Environment: Altium Systems Tasking
Tools V6.1, 87C196KD microcontroller, Nohau 196 Emulator V2.4 E, RS485
communication protocol, Custom Built Hardware, C, DSP
11/00 to Iridex Corporation, Mountain view, CA
07/01 Firmware Engineer
Developed state machine based software for medical dermatology lasers.
Worked with development of algorithms for handling and interpreting signals
from the laser diodes, as well as calibration and diagnostic functions for
the laser system. Helped develop documentation needed for FDA approval.
Debugged and corrected timing problems found within existing code. Helped
with prototype build of laser system, with documentation for the assembly line.
Environment: Macromedia C Version 2.21 for 80x196 embedded systems, DSP
Custom Built Hardware.
6/00 to GE Nuclear, San Jose, CA
11/00 Senior Software Engineer Consultant
Worked on multiple monitor chassis for various safety related functionality.
Debugged and fixed hardware/software interaction problems with use of a
variety of debug equipment. Wrote documentation required by the industry,
including SDS documentation, tracibility matrix, etc. Environment: C-386
V1.2 for VAX/VMX systems, Inhouse 386SX custom operating system, ICE-
386SX in-circuit emulator, RS485 communication protocol, Custom Hardware
9/99 to Zayante Corporation, Scott’s Valley, CA
6/00 Senior Software Engineer
Worked on 1394A compliant software for use in a variety of products.
Worked on the development of an OHCI Link Driver on a TI LV22 PCI board.
Modified/added functionality for the monitor program for the IP1394 TNF
Kernel. Helped with some development of QA software to test the
Functionality/1394A compliancy of the IP1394 TNF Kernel.
Environment: Metaware C, PowerPC403XX, uCos, pSOS, SingleStep
SDS 7.5,VSS, Custom built hardware
7/97 to Cardiac Mariners, Los Gatos, CA
7/99 Senior Software Engineer
Worked on a real-time, multi-threaded software platform for a Class 3, 3d
X-Ray Fluoroscopy system for use during heart operations. Cleaned/fixed
file system used for keeping track of configuration data. Built/coded an
API CAN interface to talk over the bus to the different consoles used to
control the X-Ray process and devices connected to the X-ray system.
Environment: Microsoft C++ 5.0, WinNT, PVCS, Custom built hardware
5/95 to Abbott Diagnostics Corporation, Santa Clara, CA
3/97 Senior Software Engineer Consultant
(5/95 to 12/95) - Developed new software package for existing
medical diagnostics instrument, providing FDA Testing and
Documentation. Environment: Watcom 9.5, PVCS.
(01/96 to 12/97) - Worked on new medical diagnostics
instrument for the company, from the design phase through to the
FDA approval process. Product is a real-time software package.
Designed/developed Real-Time sensitive Script Interpreter.
Environment: Borland C++ Version 4.52, TASM 5.0, PVCS,
Embedded 80186EC, RS-232.
11/94 to Southern Pacific/ISSC, San Francisco, CA
5/95 Software Consultant
Developed new and maintained existing pen-based software for
a GRID Corporation 8086 gridpad, used in the field by the
conductor, to maintain the track/car database for the train yard.
Environment: Microsoft C 7.0, C-Tree 4.3, PenWrite 3.0.
05/94 to Fry's Electronics, Fremont, CA
10/94 Software Consultant
Developed new code for a POS\80386 system. Part of
a team which developed POS software from a totally
new design for the company. Environment: Microsoft C
7.0, Pharlap286 3.1, Btrieve 6.0, Greenleaf DataWindows.
12/93 to The Gap, San Bruno, CA
05/94 Software Consulant
Developed new and existing code for a POS\4680
system. Code was developed to make the system
flexible for use within international stores
and a new division. Environment: Metaware High
C; 4680 BASIC; OS/2; 4680 Controller.
2/93 to Stereometrix Corporation, San Jose, CA
12/93 Software Engineer
Designed and coded new features for a large
medical imaging application. Responsible for
breaking the large system(total over 100,000
lines of code) into components and streamlining
it by redesigning and restructuring subsystems.
Also interfaced X-Ray scanner and printer with
PC. Environment: Microsoft C(5.0,6.0); PC DOS.
Summer Sandia National Labratories, Albuquerque, N.M.
1992 Graduate Internship/Software Engineer
Responsible for converting HP/BASIC to PC/C.
Designed and coded application for the study of
radiation levels. Environment: PC/DOS;
Microsoft C(4.0); HP/BASIC.
2/91 to Supplies Network, St. Louis, MO
12/91 Programmer/Analyst
8/90 to Gold Biotechnology, Inc., St. Louis, MO
2/91 Software Consultant
9/89 to St. Louis University Hospital, St. Louis, MO
4/90 Programmer/Analyst
1/88 to Sumner Group, Inc., St. Louis, MO
1/89 Programmer/Analyst
1/86 to Bohemian Savings and Loan, St. Louis, MO
1/88 Mortgage Loan Systems Administrator
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