Overall 15 years of experience predominantly in Product Design and Development of Medical Devices and Industrial Automation• Managing product qualification, NPIs & MOBs at multiple supplier location. • Leading DHF Gap Assessment and remediation wrt new EU MDR requirements for Medical device manufacturers. . Experience in fulfilling Quality Assurance requirements in Product Development Process. • Supplier management: PPAP Requirements, Supplier Sustenance support on cost savings, Line transfer, Process & design changes and new supplier qualification.• Proficient in QFD, FMEA, Complaint history analysis, Root cause analysis, Gage R&R, Capability analysis, Benchmarking• Understanding of 21 CFR 820, ISO 13485 & ISO 14971• Experienced in testing of medical devices per international standards, Proficient in handling standard lab equipment• Understanding of Biocompatibility, Packaging, Sterilization standards (ISO 10993,11607,11135)• VOC/Market survey for Emerging markets• Process Validation process development for capital equipment• Proficient in handing Change Development process for Product Change, Process Change, New Process Development & validation• Experience in design and development of Special purpose machines• Experience in developing electromechanical and hydraulic system• Design of structural, driving elements design, drive selection, standard components selection