10165 McKellar Ct San Diego, CA 92121
The Manufacturing Engineer will support manufacturing operations in the production of diagnostic systems. Individual will work closely with development engineering during the design of new products in an effort to optimize manufacturability, cost, time to stability, and the development of manufacturing documentation (specifications, drawings, instructions, etc.).
Driving continuous improvement of product and process quality, activities will include troubleshooting issues, data analysis, test design, documentation, and the implementation/validation of automated assembly equipment and process changes.
Specific roles and responsibilities include the following:
- Identify and implement efficiency and process improvements impacting process yields. Areas may include: wet chemistry processing and filling, automated assembly, fluid dispensing, plastic injection molding, laser marking.
- Collaborate with Software Engineers to create machine programs
- Provide engineering guidance for cross-functional project teams
- Solve complex problems with storage and analysis of large data sets
- Ability to drive design changes with equipment to improve performance
- Capacity Analysis
- Writing and executing validation protocols for new processes
- Identify and implement new technologies and continuous improvement to optimize manufacturing process output.
- Develop and maintain Manufacturing Instructions, SPC, Routings and Bill of Materials.
Requirements Education and Experience:
- Bachelor’ s degree in Engineering discipline; preferably Mechanical, Manufacturing or Control and Automation Engineering. Three to seven years plus experience in device manufacturing, pharmaceutical or medical device environment preferred.
- Working knowledge of sensors, machine logic, and vision systems to inspect, identify and guide parts
- Expert Knowledge with MS Excel and Visio for data analysis
- Strong working knowledge of plastic injection molding, design, and manufacturing
- Working knowledge and understanding of statistics, design of experiments, and process capability
- Experience with Industrial Networks, IIoT, and web based programming
- Working knowledge of SolidWorks, GD&T, ASME Y14.5 standards.
- Experience working in medical device or other FDA regulated environment is preferred but not required.