Bani Mohanty, PhD, MBA, CLSSBB

A passionate, hands-on, results-oriented leader and manager with experience in manufacturing, R&D, new product introduction, start-ups, process and quality improvement, product reliability, metallurgy and materials engineering, laboratory management and global supplier development with medical devices, automotive, aerospace and industrial products in regulated environment |Technical leadership, business acumen, experience and expertise in the following areas: 1) managing, leading and mentoring teams 2) manufacturing process engineering and new technology implementation 3) change management and implementation: NCR and CAPA remediation 4) product/process development: design control, verification, process validation, production qualification, regulatory submissions, IQ, OQ, PQ, TMV, ATMQ 5) project management 6) quality systems, manufacturing quality and supplier quality/development 7) materials testing and characterization lab./technical services management 8) product quality and reliability 9) continuous improvement: structured problem solving, A3, DMAIC, Lean, PDCA 10) Infrastructure development: building, replicating and qualifying production lines Specialties: Pre- and post-market solutions; problem solving; risk and reliability analysis; project management; cross-functional leadership, Six Sigma; process characterization and validation; biocompatible alloys and coatings; stents and guidewires; CRM and neuromodulation components development; orthopedic implants; test methods; ISO 13485 and FDA 21 CFR Part 820; investment casting and vacuum heat treatment; electrochemistry; corrosion; tribology and failure analysis; materials and supplier qualification; thermoforming; extrusion; injection molding; high temperature materials; thin films; process metallurgy, stainless steels, cobalt-chrome alloys, titanium alloys and Nitinol; polymeric bio-materials