Advance Manufacturing Engineer
Carlsbad, California
While serving on new project teams, worked with R&D personnel to blend design intent with design for manufacture, while bringing spine system implants & instrumentation to market* Generated in-house manufacturing work orders in support of new product development initiatives. Also prepared Work Instructions, PFMEA’s, Process Flow Mappings, and Standard Operating Procedures, as required, in support of R&D, in meeting the manufacturing deliverables required of the Design History File leading up to the limited market release.* Through both internal & external manufacturing resources, led new product verification & validation activities to contain that of the necessary IQ/OQ & PQ protocols, and subsequent reports, in the build required of the beta release of product to market.* Successfully helped launch several new implant surgical systems to market, while working in the optimum cross-functional team environment to provide the required manufacturing documentation & in process work to support the DHF.