Shweta Jadhav

WORK HISTORY

EDUCATION

SKILLS

ABOUT SHWETA JADHAV

I\'m experienced System and Software Verification & Validation (V&V) Engineer with a strong focus on design controls, risk mitigation, and end-to-end test strategy for regulated class medical devices. I specialize in translating user and design inputs into comprehensive test plans, ensuring traceability, compliance, and product reliability across the product development lifecycle.I have successfully delivered multiple formal verification cycles—owning everything from test strategy and detailed planning to dry runs and formal execution—for several Class medical device product releases. These efforts contributed to regulatory submissions and product approvals, ensuring that testing met the highest quality and compliance standards.My background includes leading verification efforts across embedded firmware, desktop applications, and mobile platforms, with deep familiarity in risk-based testing, defect triaging, and usability validation. I have hands-on experience applying standards such as FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62304 to support robust design control processes and regulatory readiness.Whether contributing to design reviews, developing automated test scripts, or analyzing risk files, I bring a detail-oriented and compliance-driven approach to every phase of development—ensuring products are safe, effective, and audit-ready.