Payal Singh

Background

About Payal Singh

11 years of experience as an accomplished Verification and Validation Lead with extensive experience in testing and managing highly complex Class II and Medical Device as per IEC 62304 and bringing a unique blend of technical knowledge, leadership skills, and strategic vision to every project. A proven ability in performing Risk Management activities including Hazard Analysis, Use/Design/Cybersecurity FMEA as per ISO 13485, ISO 14971 and IEC 62304 compliance and developing effective mitigation strategies and suggesting design changes based on Benefit-Risk Analysis. Professional Scrum Master for Agile methodology Project. Technical Skills: • Functional, Database, Cross Browser, Performance and API testing for Web/ Desktop Application and Medical device. • Embedded Firmware testing • Verification and Validation of Class II and Medical Device as per IEC 62304 • Tool and Test Method Validation • Gathering User Need, Product Requirements and Software level requirements. • Agile methodology; Scrum Master. • Risk Management as per ISO 13485 and IEC 62304 compliance • FDA documentation such as Device Description, Configuration Management Plan, Design Plan, V&V Plan, Test Protocol Development, Traceability Matrix, Design Change Records, Sample Size Analysis and Verification Reports • SOUP Analysis • Python Programming Language, SQL • ISTQB, PSM-1, PSPO-1