San Diego, California, United States
Lead design transfer to manufacturing sites and suppliers for Class I,II, and III medical devices made from PEEK, silicone, titanium, and other materials under CFR820 and ISO13485 standards. Support design reviews, equipment and process validations, Gage R&R, gage/fixture design, and capability studies. Coordinate with R&D, Marketing, Procurement and Regulatory for product launch and change activity
•Lead engineer for multiple new product launches, ranging from $2 million to $12 million in sales •Responsible for cost estimates, product routings, work instructions, and various quality documentation •Designed, built, and programmed several testing and processing centers to meet customer demands •Programmed 5-axis CNC router for use in finishing operations of plastic components •Managed multiple capital projects including sourcing, justification, and installation •Generated cost savings in excess of $1.6 million annually •Designed and implemented new production report to ease production tracking •Led improvement events to design new line layout, reduce floor space, and improve information flow •Developed novel production process to reduce initial tooling cost by 40% and per part cost by 10%