PROFESSIONAL SUMMARY:

• Advanced knowledge of testing methodology, Black box / White box testing using various QA test tools.
• Skills include Advance Windows application and Medical Device Software Testing, SQL, project management and reporting, Extensive Medical Device, GUI, Web application, and automation testing (Rational),. Networking in Microsoft Windows 2000, 2003, XP, Server 2008, Vista, Windows 7, Windows 2003, 2008 Active Directory. Protocols include TCP/IP, X25, ISDN, T1, IPX, DSL, Ethernet, Wireless 802.11, 802.16, Frame relay and Systems Network Architecture (SNA)
• FDA Guidance on General Principles of Software Validation: Final Guidance for Industry and FDA Staff
• FDA Guidance on Applying Human Factors and Usability Engineering to Optimize Medical Device Design
• FDA Guidance for the Content of Premarket Submissions for Software Contained in a Medical Device
• Remediation, 21CFR Part11, FMEA, ISO 13485, 9001, 14971, IEC 62304, 60601, 62366, IQ/OQ/PQ.

TECHNICAL SKILLS:

Testing Types: White Box, Black Box, Automation, Debug, Embedded, GUI, Web, Network, Functionality, System Integration, 3D Application, Boundary, Stress, Localization, Sanity, Regression, Build Checkout.

Testing Tools: Rational Robot 6.0, Test Director, Test Track, Bugzilla, Agil, HP Quality centerDocument Control, Clear Quest, Jira, Confluence and various Compilers. Pressure Gauges and Meters, Oscilloscopes, Power MetersLanguages: C, C++, HTML, VB, .Net

Operating Systems: MS - DOS, Windows 95/98/NT-2000/XP/2003/Vista/7/Windows 8 Mac OS9 IOS and Adroid and Real Time VX Works.

Databases: SQL Server 7.0, MS-Access.

Microsoft Products: Word, Excel, Outlook, PowerPoint, Visio, Project, Access, Source Safe

PROFESSIONAL EXPERIENCE:

Confidential, Louisville, CO

Sr. Systems Quality Assurance Engineer

Responsibilities:

• Develop, implement and maintain standards for software quality processes, systems and procedures to support the software life cycle
• Ensure that software project and process control documentation are compliant with established procedures
• Support Research and Development, Manufacturing, Production and IT in Software Quality Assurance
• Review product requirements for traceability, risk remediation and testability
• Review verification and validation deliverables for compliance with regulatory requirements
• Review software test harness / test cases for clarity and requirements coverage
• Preparation and analysis of periodic Quality Reports
• Perform internal and support external audits of products and processes
• Enhance the Quality Management System in such areas as Design Review Process, Compliance to Standards, Change Management, Software BOM enhancements, and Device History File
• Lead specific continuous improvements initiatives which will evolve into a more robust software quality assurance process. Track software problem reports and deviation up to closure
• Support the development, update, validation, and documentation of software utilized in the automated testing of printed circuit boards and finished medical devices
• Assist in maintaining, troubleshooting, and repairing software elements of automated test systems utilized in manufacturing and service
• Support IQ/OQ/PQ activities involving software based manufacturing and service equipment

Confidential, Irving, TX

Sr. Systems Validation and Verification Engineer

Responsibilities:

• Verification and Validation of various integrating modules that include testing of functional software, embedded
• Software, gap coverage, UI testing on Diagnostic Instrument in a Lab environment as well as Instrument simulation running on a Windows7 plarform.
• Duties include, planning and development of Lifecycle documentation for Test protocols, Requirements, Functional Specifications, Test Plans, Traceability.
• Additional duties include, test setup and execution, defect tracking, writing test reports, White Box, Black Box and debug testing as well as closelyworking with the company software development team to ensure correct software and hardware functionality.

Confidential, Richardson, TX

Systems Validation and Verification Engineer

Responsibilities:

• Verification and Validation of a CAD/CAM 3D dental application tool designed for Oral scanning and replication.
• Creation of documentation for Test protocols, Software Requirements, Test Plans and Traceability matrices.
• Additional duties include Defect logging, tracking and regression testing and confidence interval testing of dental scan images.

Confidential, San Clemente, CA

Lead Systems Validation and Verification Engineer

Responsibilities:

• Verification and Validation of Windows Netbook application designed for programming shock therapy for Implantable Heart defibrillation devices.
• Duties include, planning and development of Lifecycle documentation for Test protocols (IQ/OQ/PQ), Requirements, Functional Specifications, Test Plans, Traceability.
• Additional duties include, test setup and execution, defect tracking, writing test reports, Black Box and debug testing as well as closely with the company software development team to ensure correct software and hardware functionality.

Confidential, Plano, TX

Lead Systems Validation and Verification Engineer

Responsibilities:

• Verification and Validation of software and hardware for Implantable Medical devices.
• Duties included Remediation Validation to help with the resolution of present and past issues that caused a warning letter from FDA, Identify System level failure modes (FMEA), assess risk, triage, planning and development of test protocols and procedures, test setup and execution, defect tracking, process validation and writing test reports.
• Additional duties include Black Box and debug testing and working closely with the company software development team to ensure correct software and hardware functionality.

Confidential, Carlsbad, CA

Lead Validation and Verification Engineer

Responsibilities:

• Leading a team of V&V engineers to Verify and Validate embedded software application for Glucose monitoring medical devices.
• Duties Included Development of test protocols and procedures on accordance to software requirements, Black Box testing, logging defects, defect database administration and working closely with the company software development team.

Confidential, Temecula, CA

Senior V&V Engineer

Responsibilities:

• Verification and validation of ambulatory electronic infusion devices in accordance with FDA guidelines and applicable ISO standards.
• Duties included Applications testing, Embedded Device testing, Black Box, White Box and Debug testing Creating, updating, and maintaining test procedures, and test plans creating tractability matrices and test reports in accordance with FDA guidelines and applicable ISO standards.
• Creating system level test cases, execution of all written test scenarios, logging defects, performing regression test and fault tree analysis.

Confidential, Santa Ana, CA

Validation and Verification Engineer

Responsibilities:

• Verification and Validation of eye Surgical device (embedded software application) in accordance with FDA guidelines & applicable ISO standards, White box test execution of all user interface, Controller and Serial Port Communications, Creation of test protocols, and procedures from design and functional specifications.
• Additional duties included creating system level test cases, execution of all written test scenarios, logging defects, regression testing, fault tree Analysis and participation of all code review meetings.