CAREER SUMMARY

Over fifteen years experience in Quality System Management (QMS), Software V&V T
est Engineering and Software Development in industries ranging in size from smal
l start-ups to large corporations. Industry experience include: Medical devices
and semiconductor device manufacturing, wireless communication, and space resear
ch.
* Quality System Management (QMS) knowledge: FDA 21 CFR 820, ISO 9001, ISO 1348
5, and ISO 14971.
* Risk Analysis experience: Failure Mode and Effect Analysis (FMEA) and Fault T
ree Analysis (FTA).
* Project Management experience: Scheduling, prioritization, resource allocatio
n, and tracking.
* Software development experience: Software Development Lifecycle, Software V&V
, Test Automation, Object Oriented Design and Programming, National Instruments
Measurement Studio, GPIB, C, C++, STL, MFC, JScript, Python, UML and MS Windows
OS.
* Software tools experience: PVCS, SourceSafe, SVN, RequisitePro, SAP, SharePoi
nt, Visio, Microsoft Office tools such as Word, Excel, Project, and PowerPoint.
* Test equipment experience: oscilloscope, flow sensor, pressure sensor, signal
generators, IEEE488 and serial communication protocols
* Other skills include: excellent oral and written communications skills and at
tention to details.
PROFESSIONAL EXPERIENCE
PHILIPS HEALTHCARE, Carlsbad, California 2007 - Present
Manager, Software V&V Test Engineering
* Successfully staffed the software V&V engineering department and trained the
team members on software validation process and all applicable Quality System Pr
ocesses (QSPs) to ensure compliance with regulatory standards. Additional traini
ng include: submission of controlled documents via the Electronic Change Order (
ECO) process and tracking of document changes using RequisitePro.
* Successfully managed several Software V&V projects for several products inclu
ding the market-leading non-invasive mechanical ventilator (V60 Ventilator), and
supported regulatory submissions of these products for 510K, clinical, and mark
et release approvals.
* Successfully collaborated with cross-functional teams to define system requir
ements for each product, conducted Risk Management Analysis (FMECA), Hazard Anal
ysis, and provided appropriate mitigations.
* Successfully collaborated with software developers to analyze software defect
s and submit appropriate Software Change Request (SCR). Provided oversight on re
gression testing following the implementation of each Software Change Request.
* Currently managing a software development project - Test Automation System th
at will be used for testing future ventilator software products. I have authored
several related documents including: Systems Requirement, Software Development
Process, Architecture documents, and design documents, and have made several pre
sentations to various departments in the organization regarding this project.
CARDIODYNAMICS INC. San Diego, California 2006 - 2007
Manager, Software Quality Assurance
* Successfully managed several software V&V projects for non-invasive cardiac m
onitoring and diagnostic device (Impedance Cardiograph - ICG) and supported the
release of these products for 510K, Clinical, and Commercial releases.
* Authored/improved several Quality Systems Procedures (QSPs) including, Requir
ement Gathering and Documentation Process, Requirement Change Process, Requireme
nt Traceability, Peer Reviews, Software Development Process, Software Validation
Testing, and Hazard Analysis.
 * Quality Management Systems (QMS) responsibilities include: participating in t
he review of several Quality Systems Procedures (QSPs) including Design Control,
Design Verification, Design Validation, Design Transfer, Design Release, Design
Description Documents, Design History File (DHF), Failure Modes Effects and Cri
ticality Analysis (FMECA). Other activities include: internal auditing, particip
ating in Corrective Action Plan (CAPA) meetings, Complain meetings and Change Co
ntrol Board (CCB) meetings.
* Provided oversight on Quality Systems training for all members of the softwar
e V&V team.
* Allocated resources for all software validation activities.
* Part of a cross-functional team responsible for conducting Hazard Analysis (F
ault Tree Analysis - FTA).
* Authored several documents including software validation plans, validation pr
ocedures, traceability matrices, Hazard Analysis, and V&V reports.
* Coordinated software test execution during formal V&V testing. Used manual an
d automated test procedures. Test automation tool was developed with Visual C++
and MFC on Windows OS platform.
CONEXANT SYSTEMS, INC. San Diego, California 1999 - 2006
MINDSPEED TECHNOLOGIES, INC
Senior Systems Engineer
* Successfully managed several software development projects, including: Test A
utomation System that was used for validation of several silicon chipsets. The s
ystem consists of Graphical User Interface (GUI) front-end, several test equipme
nt control modules, and a large set of automated test scripts.
* The subsystems that were implemented include controls for the following set o
f equipment: SHIBASOKU AS953B MPX TV Sound Signal Generator, FLUKE 54200 TV Sign
al Generator, RHODE & SHWARZ SFM TV Signal Generator, National Instrument NI 455
2 PCI 4552 Dynamic Signal Analyzer, and HP Power Supplies. The system was implem
ented using Visual C++, STL, MFC, and JScript. Systems design was document using
UML.
* Executed several test scripts for validation of products such as TV video/aud
io encoders, DSL and SONET, and wrote the associated test reports.
* Quality Management System (QMS) responsibilities include: reviewing systems d
esign to ensure that all systems features were traced to the appropriate systems
requirement and participating in Change Control Board (CCB) meetings to ensure
that requirement changes were made according to the established design control p
rocess.
*
NATIONAL DISPATCH CENTER, San Diego, California 1997 - 1999
Software Engineer/Systems Architect
* Successfully managed an R&D project: Development of a System and Method for D
ata Compression, and was awarded US Patent (No. 6,100,824). The system was used
for wireless paging application. It enabled the organization to double the size
of the subscribers, and hence doubled the organization's revenue.
* Authored 17 technical papers on various aspects of the R & D project. The doc
umentation was used as a basis for the patent application.
* Other responsibilities include: supporting the development and maintenance of
a Voice Terminal (VT) software. Software was developed using Visual C++ and MFC
platform.
STELLCOM TECHNOLOGIES, San Diego, California 1/1996 - 6/1996
Software Engineer (Consultant)
* Developed a test harness for a startup company, and the system was used to te
st video streaming software.
UNIVERSITY OF CALIFORNIA, Visual Computing Laboratory
San Diego, California 9/1993 - 12/1995
Research Scientist
Conducted research in:
* Digital Point-Diffraction Interferometer for fluid flow visualization.
* Digital Image Processing of images generated by the interferometer.
EDUCATION AND CERTIFICATION
Phil Licentiate (Post graduate degree), Electrical and Computer Engineering
Chalmers University of Technology, Gothenburg, Sweden