Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
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Vaishnavi S Kulkarni

Senior Engineer - Verification and Validation
Bangalore

Summary

Experienced QA professional with 9+ years in the medical device domain, specializing in Verification & Validation (V&V) of embedded and software-based systems. Demonstrated success in authoring and executing test plans, protocols, and traceability matrices aligned with FDA and ISO13485 standards. Hands-on expertise in system-level testing, risk management (FMEA), and defect analysis with a strong foundation in automation frameworks and tooling (C# .NET, QF-Test, TestComplete). Known for ensuring regulatory audit readiness, collaborating closely with design teams, and driving process improvements throughout the SDLC and STLC lifecycle.

Overview

10
10
years of professional experience
16
16
years of post-secondary education

Work History

Senior Software Engineer

Siemens Healthineers
05.2019 - Current
  • Led end-to-end V&V test activities for post-processing imaging applications, including authoring and execution of Test Plans, Test Procedures, and Traceability Matrices mapped to functional and user requirements.
  • Conducted Design Verification and collaborated on IQ/OQ/PQ protocols, ensuring compliance with internal QMS and external regulatory standards.
  • Actively involved in risk-based testing, identifying essential safety features for critical subsystems.
  • Supported inspection readiness initiatives through thorough documentation practices and participation in mock audits and compliance reviews.
  • Diagnosed and documented issues through detailed root cause analysis (RCA) and tracked resolution using defect management tools (TFS, ClearQuest).
  • Refined test plans through early dry runs and pre-verification efforts in close collaboration with the design team to optimize test coverage and requirement traceability.
  • Championed test lab productivity improvements, including automation of test execution, calibration routines, and fixture validation.
  • Mentored team on V&V strategy best practices and continuous quality improvement aligned with GMP standards.

Automation Engineer

Philips India
07.2016 - 05.2019
  • Automated smoke testing processes, reducing manual testing time by 40% for X-ray backend software.
  • Developed automated use cases integrated into CI/CD using QF-Test and TestComplete.
  • Scoped requirements and designed traceable test plans for use case validation aligned with FDA guidelines.
  • Formalized testing procedures to align with Philips' quality management system.

Test Engineer

Philips India
07.2015 - 07.2016
  • Designed and executed functional and performance tests ensuring SRS compliance and regulatory approval readiness.
  • Interpreted business requirements to design effective test scenarios.
  • Conducted thorough test execution and collaborated with development teams to resolve critical defects.

Education

M.Tech - Information Technology

NIE
Mysuru
09.2013 - 07.2025

B.E. - Information Science

VTU
09.2008 - 06.2012

Skills

V&V Documentation

Test Plans

Test Protocols

Traceability Matrices

Final Reports

Formal Verification

Design Qualification

Regulatory Standards

FDA 21 CFR Part 820

ISO 13485

GMP

Risk Management

FMEA

Critical Component Identification

Test Automation

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Accomplishments

  • Authored complete V&V documentation sets including Test Protocols, Final Reports, and Risk-Based Verification Matrices for critical software releases.
  • Streamlined regression and formal verification cycles, improving test execution efficiency by 40%.
  • Successfully supported multiple internal quality audits and helped close compliance gaps through proactive documentation and test evidence collection.
  • Played a key role in the qualification and readiness of new test labs and environments for connected diagnostic imaging systems.

Timeline

Senior Software Engineer

Siemens Healthineers
05.2019 - Current

Automation Engineer

Philips India
07.2016 - 05.2019

Test Engineer

Philips India
07.2015 - 07.2016

M.Tech - Information Technology

NIE
09.2013 - 07.2025

B.E. - Information Science

VTU
09.2008 - 06.2012

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Vaishnavi S KulkarniSenior Engineer - Verification and Validation