I'm looking to contribute hands-on to compliant V&V as a senior engineer — writing and executing test scripts, driving automation depth, and owning risk-based strategy, traceability, and audit readiness for complex integrated systems.
Looking for a job
Mangesh Chandratre
@mangeshchandratre
Senior test automation engineer and V&V leader delivering compliant, risk-based validation for regulated medical platforms.
IndiaWhat I'm looking for
I’m a Senior Test Automation Engineer / Software Development Engineer in Test and Quality Engineering leader with 14+ years of end-to-end experience defining test strategy, designing validation frameworks, and governing risk-based assurance for integrated enterprise platforms—surgical robotics, CT imaging, PACS, and AI-assisted clinical applications.
My work is rooted in ISO 13485 and FDA 21 CFR Part 820 Design Controls. I’ve led audit readiness efforts with a proven record of zero major non-conformities across external audits, building RTM/traceability, CAPA evidence packages, and measurable quality metrics that translate regulatory and stakeholder requirements into executable, release-ready test plans.
I lead cross-system V&V across SIT, end-to-end flows, and UAT coordination, and I drive automation architectures for REST API validation and performance testing. In recent roles, I helped reduce regression cycle time by 20% and lowered defect escape rate by 30% through shift-left practices, peer-review gates, and traceability-aligned automation migrations to Python/PyTest frameworks.
Experience
Work history, roles, and key accomplishments
CA
Architected an end-to-end V&V strategy for the AETOS Shoulder robotic surgical platform, defining safety classification and delivering 400+ system integration, functional, regression, and performance test cases. Led ISO 13485/FDA 21 CFR Part 820 audit readiness, reduced regression cycle time by 20%, and achieved zero major non-conformities across two external regulatory audits.
CA
Designed an automation V&V framework for the surgical pre-op planning system using Selenium, PyTest, Postman REST API, and JMeter, increasing automated validation coverage from 35% to 72% within three months. Aligned automation to ISO 13485 V&V lifecycle requirements and improved sprint-exit quality gates while mentoring validation engineers in BDD-based automation and regulatory documentation sta
CA
Planned and executed hybrid functional, integration, and system-level validation for a web-based surgical pre-op planning platform, leading a 14-member team across an ~$800K engagement. Produced ISO 13485 and FDA 21 CFR Part 820-aligned validation documentation, established Jira defect triage/CAPA workflows, and designed V&V automation using Selenium, PyTest, Postman, and JMeter.
CA
Governed system-level V&V for CT scanner software across a four-year engagement, owning 500+ test scenarios in HP Quality Center with 100% RTM coverage. Validated DICOM-compliant imaging workflows, authored FMEA inputs, and supported internal/external regulatory audits with KPI dashboards and RCA disciplines that improved on-time defect closure to 95%.
CA
Executed system-level functional and regression validation for a PACS platform supporting 15+ imaging modalities, validating DICOM-compliant acquisition, storage, and retrieval workflows with full requirements traceability. Logged 80+ defects with SQL-validated reproduction steps and contributed to 99.2% diagnostic workflow stability at go-live with zero production-critical defects at launch.
QA Engineer — AI-Assisted Clinical Docs
Nuance India Pvt Ltd
Feb 2015 - Aug 2018 (3 years 6 months)
Validated speech recognition and NLP-based clinical documentation software, performing accuracy benchmarking and edge-case testing for machine-learning-driven healthcare applications. Executed end-to-end functional, regression, UAT, smoke, and sanity testing across 500+ US hospital sites and authored ISO-style healthcare software test strategies, plans, RTM, and validation reports while mentoring
Software Test Engineer — HL7 & DICOM
Lumedx Healthcare (India) Pvt Ltd
Feb 2013 - Feb 2015 (2 years)
Validated HL7 ADT (A01/A02/A03/A08/A40) message processing for CardioPACS across 500+ US hospital integrations and executed DICOM conformance testing using DICOM simulators. Designed and executed bidirectional HL7/DICOM interoperability integration tests to validate message integrity and built automated regression/performance test scripts using OpKey and TestComplete.
Prepared test plans, test strategy documents, test scenarios, test cases, and RTM for a large-scale web-based product information and eCatalogue publishing platform used across multiple brands and countries. Created and maintained automated scripts using Rational Robot and contributed to defect tracking and QA support for multi-language client configurations, using SQL Server, Windows Server, IIS,
Education
Degrees, certifications, and relevant coursework
PU
Pune University
Bachelor of Computer Applications (BCA), Computer Applications
Completed a Bachelor of Computer Applications (BCA) degree in 2011.
MSBTE
Diploma in Computer Technology, Computer Technology
Completed a Diploma in Computer Technology in 2009.
Availability
Looking for a job
Location
IndiaAuthorized to work in
Salary expectations
60k-100k USD
Job categories
Skills
PythonRegulatory And Compliance Driven ArchitectureV&V Strategy & Framework DesignSystem Level TestingRisk Driven TestingISO 13485Design ControlCAPAAudit ReadinessDICOM Standards ValidationFHIRSelenium WebdriverPostmanJMeterPytestGitHubJenkinsGitHub Co PilotJiraALM (Quality Center)TFSCognition CockpitWindchillSilk CentralWindowsWindows Server
Interested in hiring Mangesh?
You can contact Mangesh and 90k+ other talented remote workers on Himalayas.
Message MangeshGet matched with your dream remote job
Sign up now and join over 250,000+ remote workers who receive personalized job alerts, curated job matches, and more for free!
