Health Care Test Engineer

Shilpa Shree Rajashekarappa

408-***-**** *****************@*****.*** Campbell, CA-95008

Lead Senior Software Verification Test Engineer

SUMMARY

Accomplished Technology Professional with 15+ years of experience in Agile Software verification test engineer in the field majorly on Health Care - Medical Devices.

Solid experience in Health care IVD medical device like Slide scanner, IVD medical device Tissue dissection system Device, uPath software for pathologist to analyze slides, Vantage workflow software.

Hands on experience on health care software applications like Freestyle Libreview app, Librelinkup app.

Hands on experience on Agile document management system and CFR part11.

Solid experience on Testing Health Care, FDA documentation.

Hands on experience working on FDA regulatory process Test procedure, Testexecution, Test summary report, Test Readiness report, Exception log generation; software verification check list, Software verification summary report using Document generation tool.

Experience with Software Quality Assurance. Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11.

Hands on experience on mobile device testing for Finder app & Watch unlock, Instant Hotspot & Instant Wifi.

Experience in mobile testing on Android.

Successfully executed multiple Testing projects from End-to-End Testing starting from analyzing business requirement specification documents, developing Test Plans, Test Strategy, Test Scope, Test Data and defining Test Cases and Automating Test Scripts.

Highly Proficient in Tools such as HP Quality Center, HP ALM 12.0, Doc gen & JIRA.

Experienced with analyzing business requirements and validation strategy / requirements Skills include identifying test requirements, building test scenarios and test cases, developing and maintaining test scripts, Requirement’s traceability matrix (RTM), analyzing root cause of bugs and interacting with the development team to fix defects.

Experience in working from Design verification till design review.

Hands on experience in gathering client’s business requirements and converting them into User stories and logged them into tools such as JIRA, HPALM, TFS

Expertise in defining End to End testing/QA process, strategies, methodologies.

Extensive knowledge of Software Development Life Cycle (SDLC), methodologies and test Processes and Software Testing Life Cycle (STLC)

Working knowledge of Unix commands

Working experience with Data bases SQL.

Knowledge about Selenium, Test Complete.

Working experience API testing using Postman.

EDUCATION

Master of Science (MS) in Software Engineering, San Jose State University, CA, USA

Bachelor of Engineering in Computer Science, Gulbarga University, INDIA

CERTIFICATION / TRAINING

SAFE 4.0 Agile Certified

Certified AWS Sys Ops Admin

HIPAA

CFR PART 11

21 CFR 820(QSR)

FDA ISO 13485

FDA ISO 62304

FDA ISO 14971

PROFESSIONAL EXPERIENCE

Google Consultant, San Jose, CA July2023 to Present

Role: Senior Device test engineer

Projects: Finder app - Mobile device testing, Watch Unlock, instant Hotspot & Instant Wifi.

Responsibilities:

Responsible for reviewing Product requirements document with Product manager.

Worked closely with Product manager & developers to understand the business requirements and application functionality.

Creating test Plans based on Product requirements document & Created test cases.

Prepared traceability matrix for mapping between test cases and PRD.

Performed Features testing, Exploratory testing, Usability testing, Integration testing, Regression testing.

Executed test scenarios for regression testing of new modules.

Involved in defect triaging and debugging.

Analyze test results to ensure existing functionality and recommend corrective action.

Verified changes and closed bugs in a timely manner.

Involved in finding Functional issues, report bugs, take ownership of issue resolution.

Report and track issues using bug tracking tool.

Update weekly Test status summary & test execution report.

Abbott labs, Almeda, CA, July2021 to June2023

Projects: Freestyle Libre view (cloud System)

Role: Senior Software Test Verification & validation engineer

Responsibilities:

Responsible for Analyzing the Product Requirements document, and Software requirements specification documents.

Testing Libreview app & LLU app on mobile device.

Worked closely with Business, developers to understand the business requirements and application functionality.

Prepared test cases based on software requirement specifications & Product requirements document.

Participated in walkthrough and Review meetings.

Executed test scenarios for regression testing of new modules.

Used Jira Bug tracking system to report & track the defects.

Analyze test results to ensure existing functionality and recommend corrective action.

Verified changes and closed bugs in timely manner.

Experience in working with API testing using Postman.

Company: Roche, SANTA CLARA, CA

Projects: uPath, Millisect, Vantage

Role: Lead Software Test Verification & validation engineer.

Duration: March 2012 to June 2021

Responsibilities:

Gathered Business requirements and converted them into User stories.

Responsible for Analyzing the Product Requirements document, and Software requirements specification documents.

Worked closely with Business, developers to understand the business requirements and application functionality.

Prepared test plan, test cases based on software requirement specifications & Product requirements document.

Setting up the test environments.

Participated in walkthrough and Review meetings.

Executed test scenarios for regression testing of new modules.

Used Jira Bug tracking system to report & track the defects.

Analyze test results to ensure existing functionality and recommend corrective action.

Verified changes and closed bugs in timely manner.

Worked on SAFE Agile methodology.

Experience in writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report)

Worked on Test execution document, Test procedure documents, Exception log and Test summary report.

Experience in Review and update validation protocols for CFR part 11 standard.

Company: ULTRIVA Inc, CUPERTINO, CA

Project: Collaborative electronic KANBAN cards

Role: Senior QA Engineer

Duration: Dec2005-Nov2011

Responsibilities:

Analyzed the process specifications a software requirement, functional specifications and User Interface specification documents to prepare test cases.

Set-up test environments, manage and drive test schedule and related activities.

Created detailed Test Plan and Test Cases based on requirement documents.

Conducted functionality, security, performance & load testing of the system.

Participated in walkthrough and Review meetings.

Develop and maintain test scripts with respect to changes in the functional and navigation flow.

Executed test scenarios for regression testing of new modules.

Analyze test results to ensure existing functionality and recommend corrective action.

Reported and tracked defects.

Verified changes and closed bugs in timely manner.

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