20+ years’ experience in solution providing in digital manufacturing space, Tool and Jig/Fixture Design, Single stage blow molds with ASB machines. Orthopedic product manufacturing (Patient Specific Instrumentation, Hip/Knee implants, Dental Implants/Instruments, Instruments). UL certified ISO 13485 Internal Auditor.Technical Skills:•Design for manufacturability: CNC manufacturing, Plastic mold design for single stage bottle manufacturing, •Design and implementation of shop floor manufacturing processes, process documentation, process optimization, Design of CNC manufacturing processes optimization, validation, vendor development•Strong technical exposure in CAD Modeling & Concept Generation, operations of CNC machinery, pFMEA and Installation & Administration for Siemens NX and Solidworks softwares.•Machine and process verification and validation: IQ /OQ/ PQ of machines and processes. Manufacturing process design and validation.•Very good experience in NX, Solidworks, Experienced in UGPost – customization for Heidenhain and FANUC controllers, NX customization for automation of NX-Assembly, CNC programming, Expertise in CGTech- Vericut software(v6.2), CNC programming for HAAS, Heidenhain, FANUC controllers, IQ/OQ/Validation of CNC machine Operation of CNC machines – Micron, Hermle, FANUC Robodrill, HAAS, Makino, Swiss LathesGood Understanding of 21 CFR 820 and cGMP regulations