Jul 2022 – Feb 2024 · 1 yr 7 mos · Bengaluru, Karnataka, India

• Responsibilities & Accomplishments:
• Leveraging comprehensive knowledge in the development of Class III embedded medical devices, both hardware and software
• Verification Lead on Knee Navigation projects. Developed Verification tasks/schedules specific to product; verified field instructions manuals, field kit contents; developed Verification plans, reports and trace matrices, guided team members on Verification procedures .
• Developed and authored Rationale document for the CAPA, coordinated with CAPA owner, Product Quality, CAPA investigation, participated in CAPA review boards.
• Validation lead on Navigation projects, to validate the product in real-time environment and focusing on incorporating customer feedback and utilizing Cadaver research
• Engaging in Usability Engineering research including Formative and Summative and closely observed the customer usability feedbacks and recorded them to create a report.
• Continuously translating product requirements(70+) into actionable test protocols and methods for testing navigation software products
• Diligently applying software testing methodologies and adhering to ISTQB guidelines to design tests that ensure environmental adaptability, dependability, and compliance with safety/regulatory standards
• Assisting with defect documentation in JIRA, Jama and collaborating with the Change Control Board to evaluate defect priority and severity in defect management.
• SW tool validation (CSV) – Supported SMEs in authoring requirements, tests steps for three development tools, executed tests and generated validation reports, monitored overall CSV progress by creating Kan-Ban board.
• Directing a cross-functional team of 4-5 members, concurrently managing projects related to Ortho Knee and Hip planning
• Contributing to the development of traceability documentation, including manufacturing traceability records
• Consistently ensuring open and motivational communication within the team to maintain high morale and productivity

May 2019 – Jul 2022 · 3 yrs 2 mos · Bangalore · On-site

• Responsibilities & Accomplishments:
• Analyzed business requirements meticulously(about 150+), and subsequently developed test case scenarios, test protocols, and manuals
• Reviewed both requirement documents and test specifications to ensure alignment as per the international standards like EU-MDR and 510(K) submission and 21CFR part 820.
• Performed elaborate testing of the software as per the test protocols which include both functional and non-functional testing like performance, reliability etc.
• Identified and reported crucial defects, elevating software quality and efficiency
• Carried out rigorous verification and validation of life-critical defects
• Familiarity with MDR requirements for obtaining CE mark and other global regulatory jurisdictions
• Detected and highlighted any deviations from established software standards
• Spearheaded the documentation like protocol and test reports and technical manuals, ensuring accuracy and completeness
• Oversaw the maintenance and installation of various software applications, ensuring system stability and optimal performance
• Collaborated in the prototyping of vital product features, ensuring a proactive approach to product development
• Played an integral role in assuring the release quality, ensuring products met the highest standards
• Engaged closely with diverse stakeholders throughout the project's developmental life cycle, fostering collaboration and cohesion
• Initiated creating pivotal documents, including the Traceability Matrix, Test Readiness Report, Impact Analysis, and Test Summary
• Provided strategic recommendations for future systems, applications, and processes to elevate business efficiency
• Achieved the ISTQB certification and was in pursuit of the Agile Tester certification

Dec 2016 – May 2019 · 2 yrs 5 mos · Bengaluru Area, India

• Responsibilities & Accomplishments:
• Contributed to the Monitoring Solutions Project at a prominent healthcare MNC, ensuring alignment with industry best practices
• Skillfully crafted and executed detailed manual test scripts, enhancing testing efficiency
• Spearheaded the creation of exhaustive test plans, closely followed by meticulous documentation of execution reports
• Identified and reported key defects, always aiming to uplift software quality and reliability
• Diligently maintained essential assets that supported test cases and the corresponding data
• Engaged and collaborated with diverse stakeholders throughout various phases of the project's developmental life cycle
• Worked in coordination with Software Engineers and Product Owners, fostering mutual understanding and efficient issue resolution
• Expertly diagnosed, reported, and monitored challenges raised in the tracking software, ensuring swift and effective solutions
• Pioneered the development of matrices aimed at augmenting test coverage and ensuring comprehensive evaluation
• Oversaw the meticulous installation and configuration of the test environment, guaranteeing optimal conditions for testing
• Played an instrumental role in shaping the planning and progression of the testing life cycle
• Took the initiative in documenting vital artifacts, ensuring transparency and traceability in all project phases