Ventura, California, United States
Experienced development engineer from initial concept to launch into market. Documentation expert for federal or international requirements ISO9001/FDA 21 CFR 820/ ISO13485/Medical Device Directive. Diverse background with experience in multiple market segments such as aerospace, automotive, commercial products and medical devices (Class I, II and III). Familiar with various materials, fabrication and bonding methods and assembly processes (DFM/DFA): Plastics; PEEK, ULTEM, PTFE, PVDF, nylon, POM, ABS, PC, PP, co-polymers and glass reinforced resins, thermoplastic elastomers, silicones (LSR & HCR) and polyurethanes; snap-fit designs, press-fit, ultrasonic welding, adhesive bonding and mechanical joint methods.
Responsible for New Products and Sustaining Engineering
Design Engineering documents and testing for company acquisition of Intracept spinal pain relief products.