SUMMARY

• I’m a veteran Project Management Professional and have proven 18 year of success handling Software and System developing projects in the Biotech, Networking and IT industry.
• I’m experienced in managing multiple teams to design, develop, implement and deliver systems.
• My stay in the field has given me a strong foundation of both Software and Systems Development Life Cycle and has used to different project models such as Agile, Scrum and Waterfall.
• I’m an expert in managing and analyzing system requirements with requirements management tools, like DOORS, Requisite Pro and TOAD.
• As a seasoned Systems and Project specialist, I am knowledgeable with the different industries’ regulatory compliance requirements.
• My experience has made me deliver projects on schedule or even faster through effective project scheduling, tracking, budgeting and more with the help of JIRA, MS Project and more applications.
• I’m the person to go to when it comes to handling systems development projects.

TECHNICAL SKILLS

• Regulatory Affairs Project Management
• Project Scheduling, tracking, budgeting, planning
• Systems and Software Development Life Cycle
• V - model
• Waterfall
• Agile
• Business Systems Analysis
• Requirement Analysis
• ISO regulations
• FDA regulations
• Requirement management and analysis
• HP 9000 series
• Mac Power PC
• SUN 4/300
• IBM Risc 6000-R40
• Wintel-Intel x86
• Android Mini (Motorola X8 mobile computing system)
• Java2
• Java Script
• Jmeter
• Ansi C, C++, C#
• PERL
• HTML
• CGI script
• VB6
• Visual Studio 2010
• Python
• Oracle 9i, 10g
• MS Access
• MS SQL Server
• Toad
• Windows XP, 7
• UNIX, LINUX, AIX
• HP-UX-11
• VMS
• DOS
• HP Quality Center
• TestDirector 7.0i,
• SQA Suite Team Test
• Silktest, Nohau 8051 emulator
• LabView
• Test Complete
• Norton Ghost
• Viewcomm
• Serial Monitor
• Minitab
• Navision (ERP)
• VMware IOVP Workbench
• Agitar
• DOORS 8.1 and 9.2
• PVCS
• PVCS Tracker
• Mantis
• SCCS, RCS
• Framemaker, Interleaf
• MS Office
• Requisite Pro
• DICOM
• Bugzilla
• Perforce
• Visual Studio 2010
• Rational Clear case
• SOAP
• Firmware testing
• APIs

PROFESSIONAL EXPERIENCE

Confidential

Technical Writer/Design Control Documentation Specialist

Responsibilities:

• Completed Technical Documentation Traceability.
• Implemented Design Controls to complete documentation of Design Control Documentation traceability with Product Requirements Document (PRD), User Needs Specification (UN), Software Requirements Specification (SRS), Firmware Specification (FS), Gateway Software Specification (GRS), and the Project Plan.
• Worked directly with Project Manager to provide specifications for testing. Provided FMEA and Risk Management for end-client, Bruin Biometrics, SEM Scanner handheld medical device for the feet.
• The project consisted of firmware for the handheld medical instrument and software for the patient data upload function SEM Scanner that measured the ulcerative conditions of the heels and sacrum (tailbone of spine) of bed-ridden patients.

Confidential

Quality Systems Project Manager

Responsibilities:

• Designed and executed test cases for verification of software requirements, within an FDA regulated environment. Prepare and review test plans, protocols, and reports.
• Designed and developed software test tools and utilities.
• Designed and executed test cases for validation of software tools.
• Performed Unit testing in Visual Studio 2010 and Bluestone Software USB application server.
• Managed traceability between the software tests and the requirements/design/risk mitigation.
• Reviewed software and system requirements, design, and code.
• Identified, debugged, and documented software implementation defects.
• Tracked and verified proper resolution of software defects.
• Extensively used and evaluated Test Complete test tool for PDA (palm held device)
• Used HP Quality Center software test support tool to develop, execute, and report on test execution results utilizing QTP and LoadRunner (Components of HP ALM).
• Used Requisite Pro for requirements traceability and requirements management
• Responsible for Failure mode, hazards and risk mitigation analyses.
• Supported regulatory submissions, and maintain GMP systems, including design controls, document and data controls.
• Tested hardware assemblies and systems per automated protocols in LabView Modulation Tool Kit 4.2.1.
• In charge of Testing DICOM communications protocol and data.
• Responsible for following SOP, GMP, GAMP 5 with Maximo and CMMS, GDP 21 CFR Part 11, and ISO requirements. Team Foundation Server.
• Developed the application on the Android Mini (Motorola X8 mobile computing system) as well as a web UI interface.
• IEC 62304 for application of thorough Risk Management/Risk Assessment.
• Wrote SQL scripting and C++ code in Visual Studio 2010 for development and testing.
• Performed IQ, OQ, and PQ testing (Installation Qualification, Operational Qualification, and Performance Qualification).
• Developed C++ code and compiled to run in Javascript and Jmeter for a web user interface application utilizing Selenium for web browser automation.
• Developed Use Cases for development of test cases and protocols.
• Responsible for Firmware testing.
• Developed User Stories for development of test cases and protocols.

Confidential

Quality Validation Engineer

Responsibilities:

• In charge of remediation in preparation for FDA Audit.
• Developed and executed Installation Qualifications, Operational Qualifications, and Performance Qualifications for tools and fixturing for their surgical sawblade manufactured products.
• Developed Test Method Validations in accordance with FDA regulations 21 CFR part 820 (Quality Systems Mgmt), ISO-14971:2007 (Risk Management), IEC 62304, GDP, and GMP.
• Utilized Minitab data analysis tool. Wrote Process documentation.

Confidential

Validation Engineer IV

Responsibilities:

• Evaluated software and systems lifecycle (SLC) deliverables for compliance with Operating Procedures, FDA requirements, and 21 CFR Part 11 requirements and IEC 62304 (Software Lifecycle Requirements).
• Led and participated in reviews, risk analyses and other software quality assurance activities.
• In charge of Requirements gathering, test validation process analysis, software verification/validation.
• Updated the Menlo Park site's software validation process and identifying gaps in the procedures and current validation processes and mitigate the gaps to support the new software tool validation process.
• Supported 510K approval.

Confidential

Quality Systems Project Manager

Responsibilities:

• Remediated FDA Consent Decree to support the QSIP (Quality System Improvement Program) concentrating on reworking existing test cases and developing new protocols, procedures, and traceability documents in an FDA regulated environment in accordance with 21 CFR part 820, ISO-14971:2007, IEC 62304, GDP, GMP, for application of Risk Management for CDI 1000 and CDI 500 operating room perfusion systems which manages blood gases and monitors flow rate of perfused blood.
• Navision ERP Dynamics NAV 2009: ("6.00") 2009, 2009 SP1, 2009 R2.
• Wrote SQL scripting in Visual Studio 2010 and Eclipse IDE.
• Analyzed existing code to identify issues that caused source of problems in the operating room blood gas analysis.
• Performed IQ, OQ, and PQ testing (Installation Qualification, Operational Qualification, and Performance Qualification), Black, Grey, White box testing. Implemented TDD on mobile devices as well. Highly specialized effort based on previous experience with medical devices and FDA audits.
• Validated and implemented the HHD Serial Monitor Device Monitoring Studio software. Serial Monitor will intercept, display and analyze all data exchanged between the Windows application and the serial device and Terumo’s medical device, CDI 500 and CDI 1000 Monitors. It is successfully used in application development, device driver or serial hardware development and offers a platform for effective coding, testing and optimization for RS-232 and RS-485 protocols.
• Developed C++ code and compiled to run in Javascript and Jmeter (performance testing) for a web user interface utilizing Selenium for web browser automation.
• Utilized FPGA (field programmable gate array) for the integrated circuit designed to be configured by the customer or designer after manufacturing.
• Designed, developed, executed, and completed validation process for test protocol for the Blood Parameter Module Excel spreadsheet that executes calculations for blood gases.
• Acted as Administrator for Requisite Pro requirements management tool.
• Utilized Rational Clear Quest workflow automation tool.
• Developed User Stories for development of test cases and protocols, and did Firmware testing.

Confidential

Senior System Test Lead Engineer to support

Responsibilities:

• Provided software testing of a rechargeable implantable pulse generator (IPG) for spinal cord stimulation.
• Provided root cause analysis of CAPA related issues to support the QSIP (Quality System Improvement Program) concentrating on reworking existing test cases (utilizing Test Driven Development (TDD).
• Black Box testing utilizing and developing new protocols, procedures, and traceability documents in an FDA regulated environment in accordance with 21 CFR part 820, ISO-14971:2007, GDP for application of Risk Management for their implantable pulse generator, and ISO 13485. SQL scripting in Visual Studio 2010.
• Developed metrics and reports for test case development processes.
• Developed traceability matrix for test protocols to requirements.
• Participated in cross functional teams focused on Quality Planning, Design review, design verification, process, Product/process verifications and validations.
• Reviewed design input specifications based on customer requirements, review design output specifications based on product requirements.
• Developed test plans for development groups.
• Reviewed requirements, specifications, schematics and flow charts, and recommend improvements.
• Reviewed corrections to product issues in the defect management system.
• Used DOORS 8.1 for requirements management.
• Developed User Stories for development of test cases and protocols.

Confidential

Senior System Test Lead Engineer

Responsibilities:

• Developed and executed modular, functional, and system software tests for a Class III medical device, Intravascular Ultrasound and Fractional Flow Reserve software for coronary catheterization.
• Verified that all product requirements were met in accordance with 21 CFR Part 820, ISO-14971:2007, GDP, GMP for Risk Management for the coronary catheterization medical device, and ISO 13485
• Responsible for researching and refining functional system requirements and system design specifications in accordance with company SOPs and FDA regulations and assist project manager in development of software requirements and Software Requirements Specification document.
• Assisted software engineers in development of use cases, using Enterprise Architect, for rapid prototypes to elaborate functional requirements.
• Set up and maintained automation regression testing for projects using TestComplete and using Visual Studio on test machine and verified tests passed in the automated test suite. Tested DICOM communications protocol and data. Team Foundation Server.
• Developed C++ code and compiled to run in Javascript for a web user interface utilizing Selenium for web browser automation. Used Jmeter for performance testing.
• Utilized FPGA (field programmable gate array) for the integrated circuit designed to be configured by the customer or designer after manufacturing.
• Developed User stories for module and system tests and related verification and validation test plans for projects, implementing Test Driven Development (TDD).
• Performed IQ, OQ, and PQ testing (Installation Qualification, Operational Qualification, and Performance Qualification). Responsible for Process Documentation.
• Supervised, coordinated, and participated in verification and validation testing protocols utilizing Black, Grey, and White Box testing.
• Troubleshoot and debugged new electronic hardware/software systems.
• Responsible for hardware interfaces and low level aspects of embedded software products to support functional testing, firmware testing.

Confidential

Senior Verification Test Lead Engineer

Responsibilities:

• Lead Software Test Engineer in the Commercial Information Technology (CIT) department on Managed Care (MC) Contracts and SFA Brands Maintenance and Enhancements projects.
• Software test responsibilities involved developing and maintaining test plans and test cases according to GDP requirements and managing test efforts of test team. Supported Saleforce.com (SFDC) projects.
• Utilized I-Many Master Data Management software which involved CARS testing.
• Used HP Quality Center software test support tool to develop, execute, and report on test execution results utilizing QTP and LoadRunner (Components of HP ALM).
• Performed VMware IOVP (I/O Vendor Program) Workbench execution.
• Received award for implementing and delivering projects on time and with successful deployment into production environment.
• Testing performed on PC and Mac hardware supporting IE, FireFox, and Safari browsers.
• I trained User Acceptance Test teams for software releases with PowerPoint Presentations. Agile methodology environment to develop User Stories for development of test cases and protocols.

Confidential

QA Test Engineer/Lead

Responsibilities:

• Upgraded and maintained Borland Silk test project that provides automated testing for new version of a Java Swing application that drives a medical device which analyzes protein (proteomics) immunoassay analysis.
• Worked in Agile methodology environment.

Confidential

QA Test Engineer

Responsibilities:

• Designed, executed and managed manual and automated tests for Win XP/Vista and LINUX based instrument software products to support a DNA sequencing and immunoassay analysis medical device. Worked in an Agile environment.
• Utilized Borland Silk test automated test tool, T-Plan, XPlanner.
• Used DOORS 8.1 for defect and requirements management. Agile environment.

Confidential

System Test Lead Engineer

Responsibilities:

• Designed, executed, and managed manual and automated tests on the Ambulatory Bioinformatics and Communication System (ABCS) within a regulated environment according to GLP, GCP, and GDP. Developed User Stories for development of test cases.
• Developed detailed test plans from software requirements and technical design specifications. Testing ABCS web application using manual and automated test methodology using the Borland Silk test automated capture and replay test tool.
• Tested DICOM communications protocol and data. Data integrity was validated from the front end to the back end of the application with PhpAdmin database.
• Set up virtual machines for testing with VMWare.
• Produced the project development and test documentation to assure compliance with FDA regulations. Used V-Model and Waterfall methodologies.
• Provided training programs for 510K submission, Risk Management and Software Hazards Analysis/FMEA. Performed IQ, OQ, and PQ testing (Installation Qualification, Operational Qualification, and Performance Qualification).

Confidential

Senior Software Test Engineer/Lead

Responsibilities:

• Responsible for developing system/integration test plans, developing and executing manual and automated tests, writing test reports and tracking bugs.
• Utilized HP Quality Center (Components of HP ALM), automated test tool providing traceability between software requirements, test scenarios, test cases, variances, and enhancements of J2EE Enterprise Application deployed in a JBoss App Server.
• Developed detailed test plans based on software requirements and technical design specifications. As the HP Quality Center Administrator, duties included the design, development and executing test scripts with Quick Test Pro, Load Runner, and WinRunner automated test tools, and UNIX shell scripts to support data V&V. Requirements Traceability Matrix in HP Quality Center.
• Developed final test report for each product to document the quality issues found during the testing process so that fixes can be tracked. Perform analysis of J2EE based Applications in a JBoss Application Server.