SHWETA MOGALE

Execute software Verification & Validation (V&V) activities across multiple releases for regulated Class II medical-device robotic systems, supporting formal verification and product release milestones.

• Develop, review, and maintain formal test documentation including Test Plans, Test Procedures, Traceability Matrices, Test Reports, and Test Summary Reports in accordance with FDA and internal quality requirements.
• Perform manual, system-level, integration, regression, MIL, and SIL testing for complex electromechanical and robotic medical-device systems.
• Reviewed and executed requirements-based tests, use-error scenarios, instrument workflows, calibration workflows, knife retract, detachment functions, and safety-related system behaviors for the Newton surgical system verification activities.
• Analyze software and system requirements and evaluate impacted MIL/SysIL test coverage to ensure requirements are appropriately captured, verified, and traceable.
• Use Jama and Polarion to create, review, maintain, and link requirements, test cases, test results, and traceability information throughout the verification lifecycle.
• Execute formal test cases across development and release milestones, including FAT and Polarion-based verification activities, ensuring test evidence is complete and ready for formal review and release.
• Perform verification testing for functional workflows including instrument exchange, internal and external calibration, cut/seal operations, knife retract, detachment, head tracking, manual controls, and associated system safety behavior.
• Investigated test failures and software defects through analysis of test results, logs, and system behavior; collaborated with developers and systems engineers to identify root causes and verify fixes, enhancing product reliability through thorough regression testing.
• Participate in requirements reviews, test procedure reviews, traceability reviews, defect/deviation discussions, and release readiness activities with cross-functional Systems, Software, Development, Quality, and Hardware teams.
• Maintain accurate requirements-to-test traceability and verification evidence throughout the product lifecycle, supporting audit readiness and compliance with medical-device software development processes.
• Use tools including MATLAB, Simulink, Python, VS Code, Linux, Jira, Jama, and Polarion to support test development, execution, analysis, automation, and verification activities.
• Serve as a Scrum Master for the Jacobians team across multiple PIs, facilitating Agile ceremonies, tracking team progress, removing blockers, and coordinating cross-functional activities.
• Identified test coverage gaps and recommended process improvements to enhance verification efficiency, test quality, and requirements traceability, contributing to more robust software validation processes.

• Responsibilities & Achievements:
• Execute software Verification & Validation (V&V) activities across multiple releases in a regulated medical device environment.
• Develop, review, and maintain formal test documentation including Test Plans, Test Procedures, Traceability Matrices, and Test Summary Reports in compliance with FDA and internal quality standards.
• Perform manual, system-level, integration, and regression testing on complex electromechanical medical systems.
• Analyze system and software requirements; actively collaborate with cross-functional teams (Systems, Development, QA, Hardware) to clarify requirements and test coverage.
• Ensure full requirements traceability by linking tests to requirements using requirements management tools (e.g., Jama/Polarion).
• Execute test cases across various project milestones and releases, ensuring readiness for formal verification and regulatory submissions.
• Logged, tracked, reviewed, and analyzed defects using defect tracking systems; collaborated with developers to investigate root causes and verify fixes.
• Identified and suggested process improvements to enhance test efficiency, coverage, and quality.

• Project: Fast CDV
• Testing Methodology: Device & Manual Testing
• Execute software test verification & validation procedures for each phase/milestone in the project lifecycle.
• Responsible for authoring software test documentation including but not limited to: Test Plans, Test Procedures, Trace Matrix, Test Summary.
• Executed and tracked daily progress of the testing cycle, ensuring timely product release.
• Prepare Test Reports and Anomalies Reports
• Assure all issues associated with the project verification & validation activities are properly entered into the defect tracking system.
• Perform functional testing on Biomedical device
• Conducted testing on device according to operational, interface, regulatory, and end-user requirements.
• Analyze the user requirements and discuss the same with the team.
• Maintain a complete understanding of the purpose, requirements, intended use and relationships for all components throughout the project lifecycle
• Deliver accurate software test effort estimates for each phase/milestone of the project lifecycle.
• Investigated and suggested improved methods for implementing the software testing process.
• Performed Defects tracking, reviewing, and analyzing
• Tracking the Progress of UAT during the Testing lifecycle.
• Outlined project responsibilities to enhance team coordination and collaboration.
• Uploaded and organized project documents into management software. into the requirements management application. Link tests to requirements.
• Facilitated communication between project teams for alignment. with Carnival QA/QC team
• The Fast CDV Analyzer is intended to be used for the quantitative measurement of Cell Density, Viability, and Cell Diameter of Cell Culture samples in either a process development or GMP environment.
• Nova Biomedical is a company dedicated to using advanced technology to develop better blood testing analyzers for medical use. These products are called in vitro diagnostic devices (IVD). Nova is the largest privately owned IVD company in the U.S. and the third largest in the world, with over 1,200 employees globally. Our eight percent compounded annual growth over nearly a decade is more than double the IVD market growth, making Nova one of the fastest growing IVD companies in the world.

• Supported SUS UAT Testing
• Utilized JIRA and ALM
• Testing Methodology: Manual Testing
• Supporting UAT testing for Carnival web application, back end applications, creating test plan, strategies, writing test cases UAT test cases for new changes
• Executed and tracked daily progress of testing cycles for SIT and release testing, ensuring timely identification and resolution of defects.
• Interact with users to gather the requirements
• Analyze the user requirements and discuss the same with the team.
• Prepare Test Plans, Test Strategy and Action Items along with QE lead
• Researching and communicating the timeframe of the solution
• Prepare UAT test cases, complete UAT testing.
• Write an automation script for each UAT test case using Selenium
• Run and update regression automation in each cycle
• Prioritizing based on critical to the business to minimize the Risk.
• Executing UAT test scripts for Bookcc1.com and Carnival.com (includes GFT and new scripts created based on the new functionality added in the release)
• Logged defects in Rational ClearQuest and Quality Center, analyzed root causes, and ensured closure with proper resolution while coordinating with clients to resolve issues.
• Addressed and closed defects, logged issues, and retested defects for resolution and analysis.
• Tracked UAT progress throughout the testing lifecycle to ensure thorough validation of application functionality.
• Coordination with Carnival QA/QC team
• Recording and reporting the test results

• Client: Trell India
• Project: Trell
• Environment: JIRA, SQL
• Testing Methodology: Manual/Functional Testing
• Responsibilities:
• Designed tests and conducted reviews and scope analysis with team stakeholders.
• Executed and tracked daily progress of the testing cycle for SIT and release testing to ensure on-time delivery.
• Analyzing the requirements and communicating with the BA for better understanding of requirements.
• Designing, executing and validating the test cases according to functional specifications.
• Reviewed test cases and provided feedback to colleagues.
• Prepared mapping sheet of SRS and test cases.
• Performed Sanity Testing, Functional Testing, Retesting and Regression Testing.
• Identified, reported and tracked defects using JIRA Test Management Tool.
• Manage automation suite and involve in decisions about scope of automation and test data creation.
• Understand existing processes and implement an improved process which can help to boost productivity and test development.
• Help the team to implement the right testing practice based on business requirements.
• Provided timely status reports to management.
• Use available utility to automate test data quickly

• Client: UBS Global, USA
• Project: Corporate Client Solutions
• Environment: JIRA, SQL
• Testing Methodology: Functional Testing, Regression Testing
• UBS Group AG is a Swiss multinational investment bank and financial services company founded and based in Switzerland. Co-headquartered in the cities of Zürich and Basel, it maintains a presence in all major financial centers as the largest Swiss banking institution in the world. UBS provides wealth management, asset management, and investment banking services for private, corporate, and institutional clients with international service. UBS manages the largest amount of private wealth in the world, counting approximately half of the world's billionaires among its clients. Within Investment banking UBS, Investment Bank provides services covering securities, other financial products, and research in equities, foreign exchange, precious metals and derivatives. Corporate Client Solutions division provides corporate, financial and sponsor clients with expert advice, innovative solutions and outstanding execution for both simple and complex transactions. Our goal is to give our clients the best possible advice, tools and execution to help them succeed – whatever their goals.
• Understand the FRS document and analyze the requirement.
• Prepare the test case from a use case
• Execute the test case to validate customer requirements
• Reviewed test cases and provided feedback to enhance accuracy and coverage.
• Designing and executing the test cases according to functional specifications.
• Designing the Traceability Matrix to map Business Requirements with Test Cases.
• Performed Sanity Testing, Functional Testing, Retesting and Regression Testing and cross browser Compatibility Testing
• Communicated project status updates to stakeholders promptly to ensure alignment.
• Participate in scrum meeting to discuss the project the project progress report every day.
• Identified, reported and tracked defects using JIRA Test Management Tool.
• Compiled defect reports and communicated findings to the development team for timely resolution.
• UBS Group AG is a Swiss multinational investment bank and financial services company founded and based in Switzerland. Co-headquartered in the cities of Zürich and Basel, it maintains a presence in all major financial centers as the largest Swiss banking institution in the world. UBS provides wealth management, asset management, and investment banking services for private, corporate, and institutional clients with international service. UBS manages the largest amount of private wealth in the world, counting approximately half of the world's billionaires among its clients. Within Investment banking UBS, Investment Bank provides services covering securities, other financial products, and research in equities, foreign exchange, precious metals and derivatives. Corporate Client Solutions division provides corporate, financial and sponsor clients with expert advice, innovative solutions and outstanding execution for both simple and complex transactions. Our goal is to give our clients the best possible advice, tools and execution to help them succeed – whatever their goals.