SUMMARY:

• 10.5+ Years of experience in the field IT Industry with Lead Role in Medical Electronics/Medical Devices & IT Healthcare
• Skilled in formulating Project Plan, Project Estimation using WBS, monitoring project progress and ensuring delivery within time & budget norms; drove efforts for achieving an improved Service Quality, Team Productivity, Customer Satisfaction
• Worked on Agile Scrum, Waterfall, Agile - Kanban, Scrumban, Verification & Validation and Iterative Incremental Software Development Models, Experience in Web Testing/Web Services Testing
• Strong and Varied Experience with Medical Devices in Cardiology, Endoscopy, Haemodialysis, Haematology & CT/MRI
• Familiarization with IEC 62304, IEEE 829 Test Documentation, BS 7925-1, IEEE 1059, ISO/IEC 12119, IEEE 1044 & knowledge of GMP
• Experience working with windows application automation using object based tools Winium (Winium.Desktop is Selenium Remote WebDriver implementation for automated testing of Windows application based on WinForms and WPF platforms) and LDTP using Java
• Experience working with Image based tool Sikuli using Java
• Knowledge of design pattern ‘Page Object Model’ used in Selenium; Worked on projects with TDD and knowledge of BDD;
• Excels in Computer System Validation(CSV) with 6+ years of experience in Off-The-Shelf & In-House Software Development Tools with exposure to Software Verification & Quality Assurance; Performed role of Consultant for multiple customers; Performed Product FMEA
• Created various presentations including CSV case studies, Test Automation capability and quality matrices for customer demonstration
• Developed Test Automation POC using Sikuli-IDE (UI Automation) and TestComplete 10 (Key-Driven Testing)
• Proficiency in managing complete Software Testing Life Cycle (STLC)entailing requirements analysis, setting-up of test environment, creation of test scripts/cases, testing, defect tracking, metrics gathering and scheduling projects for releases
• Strong knowledge of On-Site/Offshore Software Services Delivery Model and acquired relevant international exposure by working in USA & Japan at client’s site; customer centric leader with skills in driving business growth by assisting in Pre-Sales Negotiations
• Recognized for outstanding problem solving, communication & analytical skills; skilled in managing project teams, guiding team members & enabling knowledge sharing amongst them; professionally grown in a competitive & team-work environment
• Technical expertise in working on tools like HP ALM, IBM RQM, MPP, TFS 2010, Test Manager 2010, Serena Business Mashups, VB Script, XML, HTML, IIS 6, Linux(Basic), Windows, Oracle, MS SQL 2000, MS SQL 2005 / 2008 Express and SQL Server 2008 R2
• Travelled to US and Japan for CSV Projects; Worked for WelchAllyn in US Oct-2009 to Jan-2010 ; Worked for Olympus Medical Systems, Japan in 2014

WORK EXPERIENCE:

Confidential

Verification & Validation Lead

Tool: Bugzilla 3.4.4

Responsibilities:

• Ensuring timely execution of projects; allocating resources and guiding team members during the project phase
• As lead, Responsible for Creation, Review and Rework of Design Verification Protocols
• Ensure all gaps from Requirement to Traceability are addressed
• Worked closely with stakeholder for Defect Management
• Maintains effective communication with the project manager and team members on project scope, timelines, and design changes
• Planning and coordinating the implementation and availability of the test environments
• Conducting periodic reviews for improving efficiency, reducing test cycles for effective management
• Liaising with the Team Members, Clients & other Stakeholders to develop strong understanding of the business processes
• Allocating tasks to team to execute Design Verification Protocols; Create Design Verification Reports, Defect Verification Reports, Traceability Matrix
• Participated in the Software Impact Assessment
• Maintaining a dynamic environment that motivates high performance amongst Team Members
• Provides support in other areas and people

Confidential

Verification and Validation Lead

Software: Core Java, Winium, LDTP, Sikuli, ExtentReporter, Perl 5.14.4

Responsibilities:

• Performed End-to-End testing on the Endoscopy Medical Devices (CV 145, CV 170,
• Providing support in Pre-sales for cost estimation &proposal creation; negotiating ongoing purpose & deliverables of Test Effort and assessing the progress and effectiveness of the Test Effort and ensuring proper testability focus in the software development process
• Defining the Test Strategy; Ensuring the appropriate planning & management of Test Resources; developing the Test Plan for the tasks, dependencies and participants required to mitigate the risks to system quality and obtaining stakeholder support for this plan
• For Test Automation below activities were performed:
• Setting up the Test Automation Framework including tool Winium, LDPT & Sikuli
• Identifying objects using VisualUIAVerify utility
• Defining Page Class (Using POM), Defining Test Class and Test Case Class
• Performing Regression Run, Code Refactoring and Re-Run
• Integration of Reporting using ExtentReporter
• Ensuring appropriate level of quality by the resolution of important Defects; establishing the Computer System Validation based on SOP’s and FDA Guidelines (Including Risk Identification and Assessment) as well as monitoring quality standards for the Validation activities based on customer suggestions
• Performed and Lead End-to-End execution of CSV ( 21 CFR 11 ) activities (Validation Plan, IQ/OQ, Risk Identification and Assessment, Validation Report & others) for Test Automation Framework. Lead a team of 2 Engineers;
• Performed FMEA for In-House developed tools (Based on the SOP’s)
• Organizing Internal & External Reviews and directing various function like:
• Identifying the intended use and coordinated with Subject Matter Experts for acknowledgment
• Participating in telephonic conversations and WebEx sessions for query resolutions
• Motivating Internal SMEs to be pro-active towards identifying and learning the complex functionalities of the tools
• Facilitating Requirement Gathering, Test Plan, Task Allocation and preparation of Weekly Status Reports

Confidential

Project Lead

Software: HP ALM 11.52, UFT 11.50, MPP

Responsibilities:

• Negotiated the ongoing purpose, effectiveness and deliverables of the Test Effort; planned & managed the Test Resources and established Tool Validation Process based on Standard Operating Processes and FDA Guidelines
• Ensured appropriate:
• Quality Level by the resolution of important Defects
• Testability Focus in the software development process
• Identified the intended use and coordinated with Subject Matter Experts for acknowledgment; Communicated through telephone and WebEx sessions for query resolutions and organized Internal and External Reviews
• Ensured and monitored quality standards for the Validation activities based on customer suggestions
• Identified Internal SMEs to be pro-active towards identifying and learning the complex functionalities of the tools
• Participated in requirement gathering, Test planning, task allocation and preparation of Weekly Status Reports

Confidential

Test Automation Engineer

Software: SmartBearTestComplete 10, Sikuli-X-1.0rc3, Java 6 and VB Scripts

Responsibilities:

• Performed End-to-End Testing for TEG-V5 Medical Device
• Requirement Engineering, Test Strategy Development, Test Case Development(Create/Review/Update), Initiate Approval & Sign-Off, Task distribution to team, Setup the Test Environment in the lab, Support team with queries in the lab for resolutions/troubleshooting, Perform Validation, Validation Reports
• Evaluated the tool for Automation based on customers requirement and budget; Created the Automation Scripts by using Record & Play Back function and contributed in:
• Performing Functional & Regression Testing using the tool
• Using Visual Basic as mode of Script during Record and modifying these Visual Basic scripts for Regression
• Performing GUI Testing using the tool
• Identifying the existing Manual Scripts which need to be automated for POC purpose
• Creating Test Data for Data Parameterization and Scripts using Key-Driven Testing Wizard
• Generating Sikuli, Jython Scripts for UI Automation (Record and Playback)
• Demonstrating the Automation to the customer

Confidential

Project Lead - V&V

Responsibilities:

• Managed a gamut of functions like:
• Defining the scope of testing within the context of each Sprint
• Implementing and evolving appropriate measurements and metrics
• Planning, deploying and managing the Testing effort for any given engagement/release
• Developing the entire Test Plan for the Tool Validation Project
• Led & mentored Testing Team members and provided support to the entire team for any technical issues related to process or product functionality; Arranged the testing assets required for meeting testing mandate like no. of resources, software & hardware
• Ensured adherence to the company's Quality processes & procedures and immediately notified/escalated any problem to the Senior Management; Created various checklists at different stages for team to improve the quality &reduce the reviews
• Conducted review for some complex tools their Software Plans & Reports; Established the Project Workflow, performed Risk Management using Customer SOPs as well as analyzed Weekly Project Status Report

Confidential

Software & Tools: Team Foundation Server 2010, VmWare, Test Manager, TeamSpec, Serena Business Mashups, Visual Studio 2010 with TFS, SQLServer2008 R2, NUnit, Kanban, .Net 4.0 WCF Web Services, Coded UI, Test Manager 2010, XML and HTML

Project Lead - V&V

Responsibilities:

• Defined scope of Testing within the context of each FUD (Feature Under Development) ; planned, deployed & managed Testing effort for each FUD and performed Effort Estimation for each FUD; Took part in client calls at all levels
• Participated in Requirement Analysis worked in close coordination with Developers for writing skilled Unit Test Cases; developed requirements & design for Automation Framework for continuous integration within the limitation to customer’s budget
• Took decisions & managed assets required by team to mandate Testing; Updated & reviewed checklist as per ‘Kanban’ Process for different levels of SDLC; Documented, implemented, monitored and ensured that all Testing processes are as per organization standards
• Performed Risk Management based on the Customers SOPs; Led & mentored Testing Team Members in various functions like:
• Software Tool Validation for Automation Framework as per FDA
• Development of Test Plans for Cross-Functional Testing for Browsers & Operating Systems
• Creation of Test Plan for the entire project and Test Strategy for each FUD
• Implementation of Automated Test Programs to the Automation Framework
• Review of Automated Test Cases for Coded UI
• Updating previously created Test Plan for Coded UI Testing for UI Testing
• Worked as a Defect Prevention Manager for the Project; Performed complete checklist activity during the project Execution, Reviewed Test Results & Test Reports as well as allocated tasks to team members

Confidential

Software: C, C++, Linux

Test Engineer

Responsibilities:

• Participated in Scrum Meetings; acted as a single point of contact at offshore for project execution and contributed in:
• Driving Effort Estimation, feature allocation for Testing and Test Execution functions
• Facilitating complete communication with the counterpart at Onshore for Queries & Status

Confidential

Software & Tools: Team Foundation Server, VmWare, Test Manager, TeamSpec, Serena Business Mashups, Visual Studio 2010 with TFS, SQL Server 2008, NUnit, Kanban, .Net 4.0, WCF Web Services, Coded UI, Test Manager 2010, XML and HTML

Team Lead - V&V

Responsibilities:

• Defined scope of Testing within the context of each FUD (Feature Under Development) ; planned, deployed & managed Testing effort for each FUD and performed Effort Estimation for each FUD
• Performed Verification and Validation on Quinton Q-Stress, Burdick Quest Stress & Cardiac Science CareCenter MD Stress Medical Devices
• Participated in requirement analysis; worked in close coordination with Developers for writing skilled Unit Test Cases; developed requirements & design for Automation Framework for Continuous Integration within the limitation to customer’s budget
• Performed Risk Management based on the Customers SOPs and directed a gamut of functions like:
• Creation of Test Plan for the entire project, Test Strategy for each FUD and Test Protocols for each responsible FUD
• Implementation of Automated Test Programs to the Automation Framework
• Review of Automated Test Cases for Coded UI
• End-to-End Testing and preparation of Traceability using ‘TeamSpec’ tool for entire requirements
• Plan creation for Coded UI Testing for UI Testing and preparation of Test Result Summary Report
• Demonstration to customer for some features developed at Offshore

Confidential

Software Used & Validated: C, C++, Java 6, Win OS, Linux OS, NUnit, QuickTest Pro, VS 2010, NCover, Eclipsys, SVN, Team Foundation Server

Onsite Coordinator

Responsibilities:

• Performed complete estimation of the project using WBS method as well as Cost Estimation & Risk Management at project level; Initiated the project and directed functions like:
• Setting up the Repositories for file transfer between Offshore and Onshore
• Training the Team at Onshore with Software Tool Validation Process as per the FDA
• Performed Tool Validation for 8 Developer Tools like Nunit, NCover, Visual Studio 2010 and Quick Test Professional 9.0; for each Tool created Tool Validation Plan& Validation Protocols, got it reviewed and submitted the same for execution
• Reviewed the Validation Plan, Validation Protocols &Test Results received from Offshore Team; mentored the Offshore Team in writing the Validation Protocols based on the customer expectations; performed Risk Management for each tool based on the customer SOPs

Confidential

Software: MS-Office, C#, Change Synergy and .Net Framework

Senior Verification & Validation Engineer

Responsibilities:

• Initiated and participated in client calls and requirement analysis from V&V perspective; led various functions like:
• Helping the team members to understand these requirements
• Creating Traceability Matrix for Coverage and Test Strategy for each Sprint
• Allocating tasks to team based on availability and skill set
• Prepared test cases using Boundary Value Analysis, Equivalence Partitioning, Decision Table Testing and State Transition Diagrams
• Conducted Review of Test Cases/Scripts developed by peer, executed and monitored test activities and process, performed Integration Testing and System Testing and reviewed Test Results at the end of each sprint
• Discussed Defects with team and guided them in reporting the same in best way; monitored reporting of Defects & tracked them into Change Synergy Tool; led Creation of Test Report using Excel and verification of Traceability Matrix at the end for complete coverage
• Organized& participated in Defect Prevention and Retrospective Meetings at the end of each Sprint

Confidential

Software: C#, MS-Office, VMWareand .Net Framework

Senior Verification & Validation Engineer (Team Leader)

Responsibilities:

• Initiated and participated in client calls and requirement analysis; led various functions like:
• Creating Traceability Matrix, Test Strategy documents for few iterations and Test Cases/Scripts
• Conducting Time Sheet Verification for efforts from Team
• Discussing with team how to design the Test Cases and Test Case Format for the project
• Reviewing the Test Cases developed by peer and facilitating Test Execution, Defect reporting and tracking
• Monitoring Testing activities for some iterations
• Performing Black Box Testing of the application, Integration Testing and System Testing
• Reviewing Test Results on completion and preparing Test Report using Excel

Confidential

Software: Change Synergy, VmWare, C# and .Net Framework

Senior Verification & Validation Engineer (Team Leader)

Responsibilities:

• Initiated and participated in client calls and requirement analysis; led various functions like:
• Creating Traceability Matrix, Test Strategy documents for few iterations and Test Cases/Scripts
• Discussing with team how to design the Test Cases and Test Case Format for the project
• Reviewing the Test Cases developed by peer and facilitating Test Execution, Defect reporting and tracking
• Performing Black Box Testing of the application, Integration Testing and System Testing
• Reviewing Test Results on completion and preparing Test Report using Excel

Confidential

Senior Verification & Validation Engineer (Team Leader)

Responsibilities:

• Supported a gamut of functions like:
• Creating Test Cases for Functional testing and GUI validations.
• Conducting Peer Review of Test Cases for Functional Testing and GUI Validations
• Administering Manual Testing for Functionality Testing and GUI Validations
• Performing Testing using different Modality Studies like CT, PET & MR
• Executing Test Cases, preparing Traceability Matrix for coverage and Test Summary / Results after each cycle
• Logging the Defect, verifying the fixed Defects and closing the Defects using the Defect Tracking Tool

Confidential

Software: Change Synergy, VmWare, C# and .Net Framework

Sr. Verification and Validation Engineer

Responsibilities:

• Performed a gamut of functions like:
• Creating Test Cases for Functional testing and GUI validations.
• Conducting Peer Review of Test Cases for Functional Testing and GUI Validations
• Administering Manual Testing for Functionality Testing and GUI Validations
• ExecutingTest Cases, preparing Traceability Matrix for coverage and Test Summary / Results after each cycle
• Logging the Defect, verifying the fixed Defects and closing the Defects using the Defect Tracking Tool

Confidential

Software: Bugzilla, Mozilla Firefox & Internet Explorer

Software Tester

Responsibilities:

• Analyzed the requirements received from the client in the Software Requirement Specifications; participated in preparation of Test Plans especially for Test Strategy and Creation of Test Scenarios & Test Cases
• Prepared the suggestion documents to improve the quality of the application in terms of Usability, Functionality and Performance at some places; utilized Bugzilla Tool for Defect reporting and tracking
• Interfaced with the Test Lead / Test Manager as well as conducted Review meetings within the team