Engineer Project Manager

Say Soukamneuth

Redwood City, CA *****. Tel. 650-***-****, *******@*******.***,

US Citizen.

Summary/Objective:

17+ years of experience in FDA medical devices and DOD regulated industries

plus 8 of various experience and skills from commercial enterprise high

tech industries with well-rounded knowledge and skills with proven track

records in systems integration/system and functional tests, quality

assurance/verification/validation, performance and automation testing. I am

seeking a position in Sr. QA/QE/Lead/Principle/System test engineer.

Work History

2/11-2/13. Volcano Corp., Precision Guide Therapeutic Solutions for

IVUS/FFR, Rancho Cordova, CA.

Sr. QE/System Test Engineer, Intravascular Ultrasound System (IVUS) and

Fractional Flow Reserve (FFR) SYSTEMS. Technical lead, cross function team

and change control board member. Test Plan/test procedure/ review/system

architecture document/marketing design input/software requirement specs

(SRS), software design description (SDD) and code review. Perform

verification and validation processes in compliance with FDA and

international guidelines and regulations: 21-CFR Part-820, Part-11, ISO

13485, ISO 14971, Canadian CMDCAS, European Union MDD and others. Execute

manual, automated, ad-hoc, functional tests, IQ, OQ, PQ, clinical and non-

clinical Research Use Only (RUO) apps and data. Defects management and

resolution.

Supported the Clinical Trial Team in reproducing problems and software

bugs.

SW/Tools used: Python/TestComple/Test automation, TeamCenter System

Engineering (TcSE), Enterprise Architecture (EA) System Software, various

DICOM viewer software tools (i.e., Volcano Corp DICOM Viewer, Philips DICOM

Viewer, Medis QIvus, and more), StarTeam SW bugs tracking DB, Perforce,

Agile document control systems and Perforce source code control system,

WebCats, SmartBear Code Review Code Collaborator, MFGpro, MathLab Scripts,

MiniTab statistical SW, CAP online training system, IVUS Image Export, SQL

Server database, and Siemens SW simulation tool, and more. Windows XP/7/8.

Office 2010.

Training: Extensive training in compliance with the company quality policy,

SOP, and FDA and international guidelines and regulations.

1/-5/2010. Solta Medical, Hayward, CA. A laser technology for skin

resurfacing and Skin rejuvenation company.

Sr. Quality QE engineer. Developed and executed test plans, procedures,

verification/validation/tests/reports for medical devices per the FDA,

Canadian and international quality management systems (QMS) regulations,

with various FDA and international regulations: 21-CFR-820, ISO 13485, IEC

60601, ISO 1497, ISO 9001, Canadian CMDCAS, European Union MDD and many

others.

Updated training: TUV on 13485:2010 QMS, Machinery Medical Device Directive

IEC 60601, Quality Management Systems regulations. IBM Validation of

Medical Device Software Using MDD (Model Design Development).

10/2008 - 3/2009. Lockheed Martin, Info Systems & Global Services IS&GS),

San Jose, CA. Wide Band Data System (WBDS) Data Access Routing(DAR) ground

support, Space System, DOD projects. Sr. Firmware QA Test Engineer.

DAR Control Status Function (CSF) is a complex system: redundant fault

tolerant high speed fiber optic switching control/status/FPGA/data

encryption/decryption functions. - Test plan/matrix/cases/procedures per

Mil-Std specs. Trained/mentored new hire. - Performance and stress test CSF

firmware system. Validated SNMP protocols.

SW Environment: Wintel XP Prof., Unix/Linux, Microsoft Studio .Net,

C/C++/C#, ClearCase/ClearQuest.

Trainings: QA Formal Inspection; Multi-Core Design/Develop/Debug,

conference. Mathlab/MathWorks Simulink.

6/2004-3/2008. Lumenis. Sr. QA/Verification and Validation (V&V)

Engineer/Lead.

Medical Laser Systems: surgery, ophthalmic, aesthetic, dentistry and

more.

Successfully managed many V&V projects, from start to product release,

system software for various medical laser systems. Do what it takes

attitude to get the system software tested, verified, validated and signed

off for release.

Perform hazard/risk analysis, traceability matrix for 510K submission per

quality management system (QMS) regulations in compliance with federal food

and drug administration (FDA), Canadian, European Union CE mark and other

international regulatory affairs compliances: 21 CFR Part 820, Part 11,

ISO 13485:2003, ISO 14971, IEC 60601. Many TUV - FDA's update trainings.

SDLC and QA life cycle. Managed and lead the V&V team.

Test plan/schedule/resource/detail

procedures/execute/regression/deviation/discrepancy/test and report.

Support the Clinical Trial Team.

Introduced/trained Bugzilla bug tracking system database R&D Dept personnel

by offering Bugzilla classes.

Company implemented SAP ERP/CRM processes and trainings for: FI, BI, AR,

AP, MM, MP, PM, PS, CO, PO.

Seminars: Laboratory information management system (LIMS), CLIA, Agile

methodology/process, Telelogic's requirement mgmt: dynamic object oriented

req. (DOOR). MathLab/Mathwork Simulink.

Training & Certificates: ISO 13485, TS 16949, ISO 9001, CAPA/FMEA. Mercury

Quality Center, Quick Test Professional (QTP), Loadrunner, Oracle 10i

Database, FDA/International standard rules and regulations classes.

SW: Windows Embedded CE, Visual Studio .Net, C/C++, MIPS, FPGA, Intel

CPU's. Bugzilla, Windriver.

Professional Trainings.

1/2002-6/2004. Various profession trainings.

FDA Medical Devices Regulated Industries QA Verification and validation

Classes.

QA V&V of FDA regulated medical devices per 21 CFR part 820 QSR.

Cisco Certified network Associates Courses (CCNA): Completed and passed:

CCNA-1, CCNA-2, CCNA-3, CCNA-4.

Training and update trainings on Mercury Interactive Automation Software

Test Tools.

Mercury Interactive Winrunner, SilkTest, QA Test Director/Mercury Quality

Center.

Quick Test Professional (QTP), Loadrunner.

Update trainings on Microsoft Development: Visual Basic, Visual Studio

and .Net/C#, SQL Server.

Update trainings on Oracle Data Base: Oracle Database 8i.

Sr. QA, Sr. Hands on Lead and Software Engineering QA Manager.

7/1994-12/2001. Sun Microsystems, Inc., Santa Clara, California.

Software Engineering Manager, Java enterprise 5-tiers Sun Remote Services

(SRS) monitoring applications.

Increased the SRS availability time by 20% within 4 months of my leadership

and management. Sun monitors its customers' enterprise resources (business

mission critical servers, mini and mainframe, point of sales systems, cell

phones call processing servers, high availability servers, and more) world

wide (AMERICA, EMEA, APAC centers) using SRS monitoring 5 tiers enterprise

java applications systems. With my QA Lifecycle processes continuous

improvement and new management styles and new testing methodology, the SRS

availability system up times to monitor the customer's devices were

increased by 20% within a time period of 4 months. This was a priceless

saving to the service department. This also increased the customers'

confidence and satisfactions on the product, a priceless

accomplishment.

Recruited, built, and managed talent QA team. Saved 0.25 $million/year on

resource management.

Organize SRS world wide QA Lifecycle biweekly meeting remotely for: EMEA,

APAC, & AMERICA.

Sun SRS Mgmt Center technology: Java enterprise 5 tiers system application.

Tier-1, Sun Station, placed at customers' sites gathers customers'

devices information and forwards it to tier-2 through the internet. Tier-2,

a Sun station, placed at the Sun SRS management center, which forwards

the information from tier-1 to tier-3. Tier-3, Sun SRS server, processes

the incoming information data and stores the processed data on tier-4,

Sun SRS database server. Tier-5, Sun Java remote console, queries and

displayed customers devices info and statistics in real time, system

responsiveness and various other info stored on Sun SRS database servers.

Technology: Sun enterprise Java/J2EE and Computer Associates network mgmt

monitoring applications.

Automated testing using various test tools: in custom tools (auto load OS,

client, server and applications), off the shelf tools like code

coverage, Tcl/Tk, Expect, Vista QC/Replay, Unix Shell, Xrunner, Winrunner,

QA/Silk and more.

Hands on Sr. QA Lead.

Sun High Availability Telco Server Systems (HATS) & wireless projects.

Telecommunications wireless cell phone calls processing server tests:

C/C++ API and XML schemas on secure Solaris environment.

Sun Telecommunication's management networks (TMN) and Sun enterprise

network management system (NMS) shrink wrap products testing, Solstice

Enterprise Manager (SEM), and SunNet Manager Network management.

Tested Sun SEM on SunCluster systems configuration with Oracle Parallel

Server (OPS) database management systems with VERITAS volume managers. All

network classes A, B, C, D and subnet classes.

Technology: UDP, TCP, SNMP, CMIP, GDMO, ASN.1, X.25 protocols on Ethernet

and fiber optics channels.

Sr. QA.

Test/regression/validation/I18N/interoperability test network management

systems (NMS) protocols: TCP/IP, SNMP, ASN.1Schemas, network classes and

sub-classes, SW internationalization, Java API/Java dynamic mgmt Apps.

SEM RDBMS: Oracle, Sybase, Crystal Reports, Solstice Network Storage, and

Solstice Disk Suite.

3/1992-7/1999.

Sr. QA, Sr. Hands on QA/Lead. Various consulting jobs.

Unison/Tivoli/Lotus/IBM. Santa Clara, CA. System & enterprise workload

scheduler, SAP/R3 tests

Automatic test: Winrunner, Xrunner, Perl:

functional/perform/load/stress/system tests, ClearCase/ClearQuest.

ProactiveNet, Santa Clara, CA. Automatic Test. Applications Perf.

Mgmt/Monitor (APM)/Enterprise web mission critical.

Function-performance-load-stress-automatic-test Cisco enterprise routers,

switches, w/ SNMP simulator, multi-platforms:

Solaris/Windows/Dos/Mac/Netware, w/ SilkTest. Recruit and train new hires.

Apple Corp., Cupertino, CA. Network protocols V&V/Administrator. Automated

tests: Apple & IBM LAN protocols.

3Com Corp., Santa Clara, CA. Network Engineer, upgraded Networks-Mgmt. Sys.

Automate migration of 1,500+ PC's OS/email using UNIX shell scripts.

Install/Configure 3Com Bridge/Routers. Automatic test: Winrunner/Xrunner.

Digital Communications Associates, San Jose, California.

Device drivers test: Multi platform/gateway/brouter/Ethernet/Token ring,

Netware-windows-NT-IBM-SCO-Mac.

IBM Corporation, San Jose, California. Advanced Data Storage Mgmt Sys.

Network storage. Client/server multi platform.

HW/SW: IBM Mainframe/mini/servers/workstations;

PC/Mac/AIX/DOS/Windows/Apple/Winrunner, shell scripts.

cc:Mail Lotus, Div. of IBM. Internet e-Mail/multi platforms tests. Mountain

View, California.

Sr. QA, Satellite LAN design automation test: Telematics International,

Inc., Agoura Hills, California.

06/1991-12/1991. Designed/planned/built/configured LAN on wheels/X.25

Satellite links: Shell scripts programming.

Sr. Real Time/Mil-Std Design/Quality Assurance (QA) Engineer, Department of

Defense Projects.

8/1988-5/1991. General Motors (GM), Delco Aerospace Systems Operations -

McDonald Douglas. Sr. QA Engineer.

Develop/test/automate Mil-Std-1553B bus analysis program for protocol

analyzer. Great saving for GM/McDonald Douglas C-17A transport aircraft

mission navigation systems development. SW: C/C++/ADA, Oracle database.

Technology: Triple redundant CPU's mission navigation systems, dual / quad

redundant devices: cockpit instrumentation. Kalman filters error

estimations and error corrections. Configuration release manager.

3/88-7/88. GTE Federal Systems, Needham, Massachusetts. Network Engineer.

Saved US government over 0.5 million dollars on Missiles Warning System

Network Real Time Ethernet recording using tcp/ip API Sockets. By

completing the testing project ahead of the schedules.

Dual redundant CPU's fault tolerant online transaction system; triple

redundant Ethernet adapters, and devices.

5/87-12/87. Tracor Aerospace systems Division, Austin, Texas. Sr. hands on

QA / Lead.

WIS LAN V&V Testing, open system interconnect, Open System Interconnect,

OSI 7 layers protocols.

5/85-5/87. GTE World Wide Military Systems Division, Billerica,

Massachusetts. Sr. hands on QA Lead,

World wide military commands and control systems (WWMCCS) info systems

(IS), WIS LAN. Develop/automate/validate OSI 7 layers protocols/ADA/HDLC-

X.25-TCP/IP-protocols etc. Network security. Led team deploying WIS LAN

systems for DOD: GTE, IBM, Honeywell and others subcontractors.

Real Time Military Standard Engine and Flight Control Design Engineer, and

Chip Design, Project Manager.

11/81-5/85. General Electric Aerospace Systems Division Headquarter,

Binghamton, NY.

Develop/integration/test real time F-18A fly by wires navy fighter jet quad

redundant flight/engine control/simulator.

Project manager: Successfully managed within budgets and schedules the

deployment of the Ethernet LAN with 500+ nodes for GE Aerospace Headquarter

Department: Digital Equipment Corporation VAX VMS, Data General, IBM mini,

mainframes servers, workstations and PC's, and terminal servers.

Graduate school Adjunct faculty member. State University of New York

(SUNY), Binghamton, New York.

8/1982-6/193. Taught graduate courses in microprocessors lab classes.

Education: MS & BS in computer science, State University of New York

(SUNY), Binghamton, NY.

. BS/Math/Teaching Certificate, State University, cole Normale

Sup rieure de P dagogie. French Education.

Languages: Fluently peak, read and write French, Lao, and Thai.

Skills: PC Windows NT/2000/XP/Vista, UNIX: Solaris, Linux, IBM, SCO, HP,

QNX, Mac, and mini/main frame.

Microsoft Office tools, Project, Visio, Access, PowerPoint, Outlook and

more.

Trainings

Automotive network architecture design methods. Understanding SAE J1939,

CAN Bus.

Mil-Std-461 CE, CS, RE Electromagnetic emission measurements and compliance

testing.

Micro controller uC/OS-II real time kernel. FPGA-embedded processing design

workshop for HW & SW Engineers.

Programming languages: C/C++/C#, Java, JavaBeans, ADA, Internationalization

(I18N) software development.

Windows CE embedded, Windows Platform Builder. Sun Microsystems Enterprise

JavaBeans, J2EE, SunCluster, SAP/R3/ABAP, HTML, DHTML, CSS, XML, Visual

Basic/Studio .Net, and more.

Certificates Databases: Oracle 10g RDBMS, Microsoft SQL server. Microsoft

Access, MySQL.

Certificates and test automation tools: Mercury Interactive WinRunner,

Quick Test Professional (QTP), LoadRunner (LoadTest), Mercury Quality

Center (Mercury Test Director), SilkTest. Test automation using Selenium

IDE.

Cisco Certified Network Associates: CCNA-1, CCNA-2, CCNA-3, and CCNA-4.

Test automation tools: Vista Replay GUI automation, Tcl/Tk, EXPECT, Perl

programming, TetWare, and others.

Management classes: o Management 101, Managing technical professionals,

Communications across multi cultures, managing professional growth.

Presentation skills & Advanced Presentation skills.

Dale Carnegie, CMM (Capability Maturity Modules). Sun Lean Six Sigma.

Various networks technologies: o Microsoft Network Administration.

o Telco Wireless Networks and others.

Telecom/Telcordia classes: the Next Generation Networks, Network Equipment

Building Sys. (NEBS), Common Channel Signaling/Signaling Sys. 7 (CSS/SS7)

architecture and programming.

OSI WIS LAN, world wide military cmd cntrl sys (WWMCCS) info sys various

seminars and classes.

LAN security authorization and authentication. NEBS, Network equipment

building systems.

FPGA development and programming for software and hardware training

seminars and web classes.

Spirent Communications Training Courses: SmartFabric, MPLS Performance

Suite (Multi Protocol Layer Switching), SmartWindow, SmartTCP, SmartVoIPQoS

SmartMultiCastIP, SmartApps, SmartFlow.

Self-study: Citrix MetaFrame 1.8 for Windows. IP SCSI, iSCSI, NAS,

Storage Area Network (SAN).

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