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Lead Engineer

Top Management

In my free time I love to go mountain biking, camping, and rubbing our dog's (Puffy) belly.

You can check out my personal projects here --> https://tinyurl.com/SteveLeeBikeProjects, https://tinyurl.com/SteveLeeCustomGear

- 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

Mechanical Engineer

Find out detailed information about Steve Lee, Lead Engineer in Irvine, CA

Steve Lee: Lead Engineer in Irvine, CA

Steve Lee

University of California, San Diego

University of California, San Diego