Chandra Shah
Systems & Test Engineer @ NuPulseCV | MS in Industrial Engineering | Specialist in V&V, Root Cause Analysis & Risk Mitigation
- Role
- Systems and Test Engineer at Nupulse
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Chandra Shah
I am a results-driven Validation and Systems Engineer with hands-on experience in FDA-regulated MedTech and manufacturing environments. I specialize in planning and executing complex validation/revalidation projects (V&V), and deviation investigations. I am passionate about driving continuous improvement through Lean Six Sigma methodologies and applying advanced statistical methods (SPC) to ensure cGMP compliance, operational efficiency, and product safety.
Experience
Systems and Test Engineer
Jun 2022 — Present · Raleigh, NC, US
Planned, authored, and executed validation and revalidation protocols (V&V) for software, system, and subsystem requirements to support IDE clinical trial submissions- Led updates to Design and Use Failure Mode and Effects Analysis (DFMEA, UFMEA) and Hazard Analysis to implement preventative measures- Performed comprehensive statistical analysis on executed test protocols using Minitab and applied Statistical Process Control (SPC) to monitor critical parameters- Drove CAPA resolution by designing and executing test protocols to evaluate different product configurations, identify root causes, and implement verified corrective actions
Education
North Carolina State University
Master's degree, Industrial Engineering
Dr DY Patil Institute of Technology
Bachelor's degree, Mechanical Engineering
2017 — 2021
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