San Jose, California, United States
• Enhanced Class III medical device performance, reliability, manufacturability and sterilization properties of an orally ingestible drug delivery combination device, contributing to 95% preclinical/clinical success and 50X increased drug payload
• Led multiple New Product Development (NPD) projects through design and rapid prototyping (idea to CAD, tooling, CNC, molding, IQC within 24 hours) of thin-walled thermoplastics, silicone, and butyl rubber components for complex, compact medical device assemblies (actuators, valves, bladders), meeting tight deadlines. Leveraged precision GD&T and tolerance stack-up to achieve sub-0.001” tolerances, optimizing fit, biocompatibility, manufacturability and tripling shelf life
• Designed and built test fixtures, semi-automated manufacturing equipment and associated protocols across a wide range of device components, programmed robots for 0.001” precision assembly, developing and characterizing joining processes (2D/3D heat staking, adhesive application), directly contributing to successful V&V completion
• Drove production improvements, boosting throughput by over 5X through part redesign collaborating with automation, and cutting defect rates by over 90% via root cause analysis (e.g., bonding failures, cracks) and corrective actions
• Authored comprehensive FDA-compliant documentation (Verification & Validation, Product Spec, DFMEA, IQ/OQ/PQ, MPI, SOP, WI, URS, engineering drawings) ensuring regulatory compliance and smooth team handoffs
