SUMMARY

• Senior level professional with 18 years of wide - ranging experience in Software Quality Assurance, Software and Firmware Testing, Software Verification & Validation, Build, Release and Configuration management in Medical Devices, Biotechnology and Pharmaceutical industries.
• Hands-on experience in ISO 13485: 2003 Medical Device Quality Management System Requirements, FDA 21 CFR Part 820 Quality System Regulations, EN ISO 14971:2012 Risk Management, IEC 62304 Medical Device Software - Software Life Cycle Processes, IEC 60601 Medical Electrical Equipment, Medical Device Directive (MDD), 21 CFR Part 11, Annex 11, PIC/s, cGMP, ICH, EU, CMS CLIA/CAP, GAMP 5, SOX, SEI CMM, IEEE, IEC/EN/AAMI, MDD 93/42/EEC, CE mark, FDA 510(k) submission.
• Working knowledge in establishing SQA automation objectives and strategies across multiple projects utilizing state of the art automation tools and technologies. Test automation development in C, Silk (4Test), Shell (sh, ksh, bash), and Perl scripting in Windows, UNIX, and Linux environments.
• Hands-on experience with MFC, Web 2.0, NET, COM, DOM, Active Directory, Source Code Control, SCM, DLL, Multithread Process, Internationalization (L18n), Localization (L10n), SaaS, LDAP, SAP, DICOM, HIPAA, Medical Devices, Clinical Trials, In Vitro Diagnostic (IVD) Devices, Medical Diagnostic Imaging, Control Systems, Robotics, Embedded, Software Calibration.

TECHNICAL SKILLS

Hardware: IBM & PC Compatible and Mac. Installed SCSI Cards, IDE, Hard DrivesNetwork Cards (Ethernet, Token Ring), CD ROMs, Modems, USB

Operating Systems: Windows /NT4/ME/XP/Vista/7/8/CE, Unix (Solaris, BSD), LinuxVxWorks

Test Tools: QTP, SilkTest 10, WinRunner, LoadRunner, TestComplete

Databases: Oracle 8-11, MS SQL Server 10, Verity Engine, File Maker Pro, Sybase

Applications: IIS, Web 2.0, WebLogic, Apache, MS Visual Studio, TFS, Silver Light, Share PointFramemaker, Passolo, Agile PLC, Omnify, Windchill, VMware, InstallShield

ERP/CRM: SAP, Microsoft Dynamics, Salesforce, Siebel, PeopleSoft, NetSuite, Workday Communications

Packages: CGI, Unix Internals, TCP/IP, DNS, WINS, HTTP, SOAP, DHCP, NDDS RTI

Languages: C, VBScript, HTML/XML, JavaScript, 4Test, TSL, Perl, 4NT batch, Fortran

SCM Tools: Hudson, SVN, CVS, TFS, Perforce, ClearCase, Visual SourceSafe, Ant, MavenBug Tracking HP ALM, Soffront Track, ClearQuest, MKS Track Integrity, Jira, Bugzilla, RemedyTestTrack Pro, Elementool, Trac

Test Management: DOORS, HP ALM, MKS Integrity, RequisitePro, TestTrack RM, Caliber, ClearQuest

PROFESSIONAL EXPERIENCE

Confidential, Concord, CA

Lead Software Engineer

Responsibilities:

• Leading Confidential software verification and validation activities as a part of the overall software development process for Liberty Automated Peritoneal Dialysis and Hemodialysis Delivery Systems.
• Defining and developing V&V strategy for integrated medical device systems with Electro-Mechanical, Fluidics, Optics, Electronics, Embedded Software and Disposables.
• Ensuring V&V documentation compliance with FDA 21 CFR Part 820, 21 CFR Part 11, EU Annex 11, IEC 62304 Medical Device Software Lifecycle, ISO 14971 Risk Management, Medical Device Directive 93/42/EEC, IEC 60601 Medical Electrical Equipment.
• Developing test approach, test design, test plan, test procedures, scripting, algorithm verification, FMEA review and risk management, executing testing with engineering traceability to ensure completeness, accuracy and testability of product requirements.
• Performing verification testing on embedded control system software (VxWorks) to integrate hybrid trials and to gain increased real-time data access for a variety of clinical scenarios.
• Coordinating software verification and validation (Unit Testing, Code Walkthrough, Functional Black Box/White Box testing, Intended Use/System testing) to ensure dat software is validated in accordance with established requirements and procedures.
• Contributing to SCRG (Software Change Review Group) and SPG (Software Planning Group) meetings to review defect fixes/proposed changes, implementation schedule, deliverables, V&V requirements; V&V results; and to recommend software release.
• Coordinating planning and implementation of corrective actions and preventive actions (CAPA) for software nonconformities.
• Providing Software Quality Assurance technical guidance/training and support to all departments dat develop or use software to ensure product quality and safety and conformance to regulatory requirements.
• Managing software release and implementation activities. This includes revision control, configuration management, and installation of approved software in Production Manufacturing areas.

Confidential, Foster City, CA

Software Test Lead

Responsibilities:

• Led SQA, validation and verification of GxP computerized systems in compliance with 21 CFR Part 11, EU Anex 11, GAMP 5, SOX, PIC/S, HIPAA, SOPs guidelines performing testing of TrackWise 8.4 and Documentum D2.
• Worked on test design, test scoping, resource allocation, configuring installation, deployment, software design reviews, configuration, go/no go decisions and reporting.
• Contributed to development of SRS, FRS, URS, Design Specification, Risk Assessments, Risk Management Plan, Test Plan, Test Procedures, Test Cases, Test Traceability Matrix and Test Reports. Run complete test cycles for each product revision.
• Participated in requirements development using risk-based approach to comply with EN/ISO 14971:2012 Risk Management to determine the scope of V&V for GxP systems.
• Performed validation of data migration on Oracle 11.2.0.3 on Source DB, Target DB and Staging Area. Migration test included set up, pre-migration activities, migration code execution, migration logs collection, data mapping, verification of migrated workflow.
• Led V&V activities for implementing TrackWise 8.4 and Documentum D2 software upgrades across Dev, Test, QA and Production environments (Apache, Weblogic).
• Managed electronic routing of required documentation ensuring compliance to current procedure for e-approval. Communicating status, solutions, concerns in a timely manner within the team to facilitate and address issues within the projects.
• Tested integration of Documentum D2 to SAP Work Management (WM) module to manage document and data connectivity, and associated regulatory compliance processes within the context of SAP application objects.
• Used SoapUI 4.6.0 tool to validate web services dat utilize the standards like XML, WSDL, SOAP and Java Message Service working on different servers (Oracle WebLogic, Apache Tomcat).

Confidential, Palo Alto CA

Software Quality Lead

Responsibilities:

• Led SQA team developing and maintaining software verification and validation of product, non-product and infrastructure projects under FDA, ISO, cGMP and GAMP.
• Tested the migration of the legacy systems documents and metadata (FileNet, SharePoint, Protégé, DoCTR) to Documentum D2.
• Authored V&V package (V&V Test Plan, Risk Management Plan, Test Cases, Compliance V&V Plan and Report, V&V Test Summary Report.
• Participated in requirements development, software design reviews, testing, configuration, go/no go decisions and reporting.
• Performed V&V of design controls to ensure the compliance with FDA QSR, CLIA, ISO 13485, ISO 14971, IEC 62304 and MDD.
• Conducted SDLC Agile model for software V&V of manufacturing environment (Class me & Class II products), performing software validations on software for instrument controls, quality data tracking and system software.
• Managed HP ALM (Application Lifecycle Management) 11.0 to manage requirements, test planning, test execution and traceability.
• Performed data integrity testing on Microsoft SQL Server 2008 to access and manage the Database Engine, Analysis Manager, and SQL Query Analyzer.
• Conducted software testing on Saba LMS application hosted and delivered via Software-as-a-Service (SaaS) model with an impact on Performance, Network Security, System Backup, Disaster Recovery, Data Integrity and Record Retention.
• Provided validation representation of Change Control Board to ensure and document dat GxP systems are maintained in the validated state in production

Confidential, Hayward CA

Software Test Lead

Responsibilities:

• Led software testing and V&V activities on OptiScanner, an automated, plasma-based bedside monitoring system intended to manage patients’ target glucose level.
• Performed testing and V&V of design V&V, software, embedded control system (Windows CE, VxWorks), Electro-Mechanical, Fluidics, Optics, Electronics and Algorithm.
• Responsible for overall testing strategy, test planning, test case development at all Testing Phases including Unit, System, Integration, Performance, Security and UAT.
• Developed SOPs for 21 CFR Part 11 Electronic Records; Electronic Signatures and IEC 62304 Software Life Cycle Processes to ensure compliance with FDA QSR.
• Authored URS, SRS, Software Design Verification and Validation Protocols, Design Control Plans, Trace Matrices, Validation Summary Reports, Qualification Protocols.
• Supported Bugzilla bug tracking system, working with the development team on reported issues. Chaired CCB to set priorities, resolve issues and escalate testing.
• Collaborated with the Embedded Software Development team during daily scrums to assist with developing planning and demonstrating the completion of software artifacts through test execution.
• Performed installation, programming and testing of real-time embedded software on Instrument part of OptiScanner medical device.
• Continually researched and recommended new tools, technologies, mechanisms and process improvements to accomplish more efficient and productive environment for achieving the highest quality products.

Confidential, Alameda CA

Sr. Software QA Engineer

Responsibilities:

• Participated in software V&V of Abbott Diabetes Care Orion project, the Therapy Management System software and medical device (Insulinx glucose meter).
• Worked for the verification engineering team, developing and maintaining verification and validation of product, non-product and infrastructure projects,
• Authored and maintained V&V documentation deliverables dat comply with FDA CFR Part 820, FDA CFR Part 11, cGMPS, ISO 13458 and HIPAA guidelines.
• Performed design verification and validation to ensure dat design control process is in compliance with QSR, CLIA, ISO 13485, ISO 14971, IEC 62304 and MDD.
• Utilized Rational DOORS requirement management system as a company tool to follow requirements traceability during design and development process.
• Used DOORS as verified electronic signature system for protocol approving and execution with output to formal documentation (DHF, DHR, DMR) dat is reviewed, approved and controlled in Agile product lifecycle management system.
• Queried and verified Oracle database tables using EO Modeler and SQL Plus.
• Executed SQL, Perl, and UNIX scripts to perform updates and queries in a real-time relational database engine.
• Supported Support 510K submission, TUV testing, and FDA approval process.

Confidential, Palo Alto CA

Sr. Software Verification & Validation Engineer

Responsibilities:

• Performed software verification and validation of Confidential medical devices for radiotherapy, radiosurgery, proton therapy, and brachytherapy treatments.
• Defined test strategy, designed and developed V&V documents form software requirements, architecture designs, and code of complex embedded real-time systems.
• Ensured the compliance with FDA QSR design control requirements 21 CFR Part 820.30, 21 CFR Part 11, IEC 62304 Software Life Cycle Processes, ISO 13485 Quality Standard, EN 60601 Safety Requirements for Medical Electrical Systems and HIPAA.
• Led software verification and validation activities on Novalis Tx™ radiosurgery system with 4D imaging using PET/CT scanners, respiratory gating and IMRT (Intensity Modulated Radiation Therapy).
• Developed and maintained V&V project schedules, CCB chairing in cross-functional team environment and providing engineering test support during all phases of SDLC.
• Supported training of personnel in requirements of quality tools and techniques, QMS based on ISO 13485 and FDA 21 CFR 820 regulations.
• Verification testing on embedded control system software (VxWorks) to intergrate hybrid trials and to gain increased real-time data access for a variety of clinical scenarios.
• Performed Varian’s products Internationalization (L18n) & Localization (L10n) testing using Trados and SDL Passolo software localization tool.
• Performed ASCII character sets verification, text filters, hyphenation, spelling, and sorting rules.
• Tested for language translation, data formats and setup options, culture-bound graphics and output, National Language Support (NLS), DBCS, Unicode normalization, locales and languages.

Confidential, Davis, CA

Software Quality Lead

Responsibilities:

• Performed software quality assurance, testing, build, release management and deployment of software for Schilling Robotics products under FDA, ISO and GxP standards and regulations.
• Reviewed and analyzed software requirement, design and product specifications, developing and executing qualification test plans, test procedures, test scenarios and test cases.
• Run complete test cycles for each product release monitoring and analyzing test results, collecting test metrics and conducting test reporting.
• Performed verification, validation, simulation, end-to-end testing, debugging, defect isolation, and fixes of new software dat provide control, communications, and power distribution for virtually any remotely operated system with multi-carrier real devices.
• Maintained and administered the Build System dat included Subversion, Visual SourceSafe, Visual Build Pro 6 and InstallShield dat power a complete build process.
• Prepared FDA CFR Part 11 Gap assessments to develop remediation plans to improve the business process and the efficiency of GxP system.
• Participated in Change Control Board (CCB) activities with the cross-functional group (R&D, Systems Engineering, Affairs, Marketing and Operations).
• Led the activities for continuous development and improvement of all engineering team quality policies and processes in accordance with FDA and international standards for medical devices.

Confidential, Clara, CA

Senior Software Verification & Validation Engineer

Responsibilities:

• Performed V&V of medical devices, VISX WaveScan and STAR Excimer Laser Systems software and firmware under FDA, ISO and GxP standards and regulations.
• Performed design verification and validation to ensure dat design control process is in compliance with FDA QSR, CLIA, ISO 13485, ISO 14971, IEC 62304 and MDD.
• Analyzed system’s functional specifications, developing and implementing test plans, test cases, test scenarios, and test metrics. Run complete test cycles for each product revision.
• Comprehensively performed unit and system level software testing/troubleshooting and documented software issue reports to be tracked and resolved.
• Participated in Change Control Board (CCB) reviewing proposed change control, assisting in the validation impact assessment for GxP systems.
• Aided program mangers and regulatory specialists by providing deliverables for FDA PMA/510K, and CE Mark submissions.
• Developed and implemented a Web interfaced test case management database for test case creation, management and execution based on File Maker Pro 5.0 platform.
• Worked in a fast paced team environment to interface regularly with electrical, back-end software, mechanical and system test engineers on system level design and test development.