Steve Lee: Lead Engineer in Irvine, CA

- Architected and designed a multimodal medical device comprised of various electromechanical sub-systems. - Developed a microfluidics based consumable cartridge for SARS-CoV-2 detection. - Created and managed assembly flow for device as well as QC criteria and supporting equipment. - Carried out risk management and assessment (FMEA, FMECA). - Lead DFM and DFA of components and assemblies. - Developed design requirements and created and managed tests for verification and validation activities. - Worked closely with all departments (marketing & sales, assay development, production, quality, and regulatory) to understand user needs and develop design requirements. - Device design took advantage of sheet metal, injection molded plastics, machined metal, and 3D printed plastics to meet performance criteria and still come in cheaper than competitor products (<$5k vs >$20k). - Helped build QMS system for compliance with ISO 13485, 21 CFR 820, CE, and MDSAP standards and regulations. - Created and maintained DHF documentation to support FDA EUA submissions and CE Mark submissions - As part of management team, developed yearly and quarterly development targets - Setup and managed the machine shop which included various hand tools, machine tools, and a 3 axis CNC mill

- Assembled and tuned automation equipment for high speed disposable bottle assembly. - Designed subassemblies and conducted validation testing for a high throughput medical diagnostic platform. - Developed design documentation for medical diagnostic devices in-line with FDA 13485 guidance. - Participated in failure analyses of consumer goods products and issued suggestions to improve reliability and function. - Managed the machine shop which included machine maintenance and safety training for ISO 9001 auditing purposes. - Gained strong knowledge of sheet metal, machined part, and 3D printed part design