Tanya Singh

• Led global failure investigations and root cause analysis of product complaints in compliance with FDA (21 CFR 820), ISO 13485, and MDR

• Analyzed product performance data and logs to identify failure modes, trends, and use-related risks, improving product reliability and reducing backlog

• Applied structured problem-solving methodologies including 5 Whys, Pareto analysis, and trend analysis to isolate root causes and recommend corrective actions

• Collaborated cross-functionally with engineering, manufacturing, and regulatory teams to validate findings and implement solutions

• Supported risk assessment and quality system compliance, ensuring alignment with GMP/GLP standards

• Authored detailed investigation reports, clearly communicating findings and recommendations to stakeholders

• Designed and executed experiments to evaluate image processing techniques, improving diagnostic accuracy by 30%

• Developed Python-based pipelines to test hypotheses and refine system performance

• Analyzed system outputs and variability to identify failure points and optimize performance

• Improved reliability and consistency of diagnostic workflows through iterative testing

• Conducted large-scale data analysis on clinical datasets to identify patterns, anomalies, and system-level inefficiencies.
• Applied statistical methods (regression, trend analysis) to analyze system behavior and user interactions.
• Led cross-functional projects, improving workflow efficiency by 20% through structured problem-solving.

• Led a meta-data analysis project on the COVID-19 Open Research Dataset (CORD-19), synthesizing large-scale datasets to derive insights on clinical patterns and outcomes
• Conducted user interviews and primary research to understand clinical workflows, user needs, and decision-making patterns in healthcare settings
• Performed task analysis and user workflow evaluation to identify inefficiencies and improve process outcomes across research and operational activities
• Applied statistical methods (including regression analysis) to analyze user behavior and system interactions, translating findings into structured insights
• Directed 15+ cross-functional projects annually, improving workflow efficiency and increasing on-time delivery by 20% through structured planning and execution
• Synthesized complex data into reports and presentations to support user requirements, decision-making, and process optimization