Manufacturing Automation — Medical Device Test Strip

Led hardware automation for Class II test strip manufacturing, increasing throughput by 22% and yield by 18% while delivering ISO 13485-compliant systems in just 3 months.

Automating manual production steps to scale manufacturing to 10,000+ units/week.

Designing human-centric systems for operators with intuitive controls and robust error reporting.

Reducing yield variability through automated test, validation, and process monitoring.

Hardware: PCB design, DFM/DFA, BOM management, manufacturing scale-up

Firmware & Motion Control: ARM, microcontrollers, Arduino

Quality & Regulatory: ISO 13485, MDSAP, V&V, risk management, CAPA

Automation & Testing: Process automation, human-centric design, yield optimization