Jan 2022 – May 2023 · 1 yr 4 mos · Bengaluru, Karnataka, India · On-site

• Responsible for executing and managing end to end testing/ verification/ reliability activities for Xray & Mammography medical devices/applications, for new and in-market products.
• Involved in system reliability, requirement-impact analysis, V&V planning/ stratergy, test effort estimation, regression, component, functional, performance, integration & explorative testing.
• Responsibilities:
• Product Reliability end-to-end ownership, reliability strategy, target definition, mission profile, setup, scripting (python), execution, failure analysis and logs analysis.
• Authoring reliability scripts, automating log analysis and data analysis
• Setting up, troubleshooting, maintaining, and validating system reliability setup
• Performing system verification impact assessment, to derive time-effort estimation & prioritization.
• Developing system level test strategy, test plans, test cases to ensure end-to-end verification of medical devices consisting of hardware, firmware, and software components.
• Involved in test case reviews, test env. setup, HW-SW integration, regression/ system test execution, etc.
• Authoring tangibles like V&V plan – summary, steering guide, test reports, config control, etc.
• Contributing & coordinating PI planning, creating-assigning test features, user-stories, tasks, etc.
• Tools: MyWorkSpace, Rally, IBM DOORS, Jenkins, Git, in-house scripting, and cycler framework
• Standards: ISO 14971, ISO 13485, IEC 62304, and FDA General Principles of Software Validation

May 2020 – Jan 2022 · 1 yr 8 mos · Gurgaon, Haryana · On-site

• Responsibilities:
• ➢ Performing software risk management, tangible verification, hazard analysis, cybersecurity, and usability engineering activities for critical Software as a Medical Device (SAMD) as an independent Sr. Software Advance Quality Engineer
• ➢ Analyzing and providing inputs to software safety test plans/ protocols, SRS-DI, DIOVV, Intended Use, SI-UM-IFU and V&V strategy as per the risk evaluation/ mitigation and risk controls identified.
• ➢ Performing complaint analysis, PMS report analysis, FMEA, FTA, DHF reviews, and CAPA analysis
• ➢ Performing software analysis and review, requirements analysis, system risk analysis, and software reliability analysis
• ➢ Collaborating with cross-functional New Product Development teams through a quality management system
• ➢ Ensuring software V&V activities comply with an internal quality management system, quality gates, design philosophy, FDA-ISO standards, and regulatory bodies
• ➢ Author, review, research and evaluate project documentation like Risk management file, Risk assessment and risk control, Usability input file, QA metric, PMS report etc. for software release for compliance
• ➢ Working on Class III SaMD software application that provides surgical navigational guidance to the end user
• ➢ Proficient in Agile Methodology, V&V activities, V-model process documentation
• Tools: PTC Windchill PLM, JIRA, Embedded C language
• Standards: ISO 14971, ISO 13485, ANSI AAMI IEC 62304:2006, and FDA General Principles of Software Validation

Jul 2017 – Mar 2020 · 2 yrs 8 mos · Gurgaon, Haryana, India · On-site

• Responsibilities:
• ➢ Performed sub-system and system testing of onboard Automatic Train Protection (ATP) software in compliance to European Rail Traffic Management System/ European Train Control System
• ➢ Execute V&V test activities as per the V model SDLC, like requirement analysis, test planning, test case development, environment uplift and troubleshooting, test case execution, scenario-based testing, while adhering to SIL4 safety standards for the braking-speed supervision functionality package
• ➢ Technical knowledge of ETCS levels, modes, packets, brake curves, SDM, target supervision, MRSP, MA etc.
• ➢ System testing, defining regression scope, Integration testing, HSIT, test planning, test log analysis, bug recreation ➢ Responsible for req. coverage analysis in IBM DOORS, mapping test-req for updated requirement traceability matrix
• ➢ Ensuring hardware-software integration of the hardware-in-loop system test bench by installing, configuring, and troubleshooting latest ATP software with the test hardware rack and subsystems
• ➢ Perform test suite baselining and versioning in IBM rational synergy with CI/CD of software packages
• ➢ Defining scope, prioritizing, and submitting bugs and non-conformity reports for my functionality team
• ➢ Analyzing failed test cases, fields reports and data logs to identify failed requirements and report bugs
• ➢ Test case scenario making, interpreting requirement, scripting in C#/ automation, modification and review ➢ Initiated version control and maintained configuration record for system test bench w.r.t weekly software builds
• ➢ Follow the agile way of working, support PI planning
• Tools: IBM DOORs, IBM Rational Synergy, IBM RTC, UNITe Test framework, ERA_Braking_curves_tool_v4, VectorCAST, Visual Studio, and scripting in C#
• Standards: CENELEC EN50128, Agile-Scrum framework and ERA UNISIG Subset-026 System Requirement Specification

Mar 2015 – Jun 2017 · 2 yrs 3 mos · Manesar, Haryana, India · On-site

• Worked in VA/VE projects involving software development of ECU, for the leading Indian automakers
• My responsibilities ranged from customer requirement analysis to ensuring final software delivery
• Actively involved in software validation, testing, modification and debugging,
• Wrote extensible code, including experimentation and multiple iterations on SIL/ HIL systems and vehicle

May 2014 – Feb 2015 · 9 mos · Gurgaon, India · On-site

• Successfully completed an Industrial monitoring solution (H/W and F/W), concept to finished product.
• Performed unit and end-to-end system testing of the hardware and software of the Remote Terminal Unit.

Jan 2014 – Apr 2014 · 3 mos · Noida, Uttar Pradesh, India · On-site