Nishant Hemant Hawaldar
Mechanical Engineer @Sio2 Medical Products
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WORK HISTORY
Mechanical Engineer @Sio2 Medical Products
Auburn, AL, US
Product Development: Spearheaded the design and production of COP vials (ISO 8362), prefilled syringes (ISO 11040-4, ISO 11040-6, ISO 7864, ISO-9626, ISO-7886-1, ISO 11608-1), blood tubes (ISO 6710), and Polypropylene transport tubes (ISO 6717) all in strict alignment with FDA 21CFR820 & ISO 15378. Enhanced existing sterile barrier system (tub, nest, & Tyvek®) designs following ISO 11607-1 & ISO 21882.• Root Cause Analysis: Led comprehensive RCA efforts, effectively resolving customer complaints tied to challenges within ISO Class 5 Aseptic Drug Filling machinery, resulting in a 15% improvement in the first yield pass rate. Collaborated directly with customer technical and sales teams to rectify transportation, manufacturing, and packaging issues. Executed Design of Experiment (DOE), created dFMEA, and pFMEA, and assisted in validation (IQ, OQ, PQ).• Technical Documentation: Developed comprehensive Work Instructions for novel and refined manufacturing processes, cGMP process evolution, and equipment operation guidelines. Devised ASTM-compliant test methods within the product development context. Wrote User Requirement Specifications based on application and customer inputs. Executed Design and Development procedures in line with ISO 13485 Quality Management Systems.
EDUCATION
Sinhgad Institute of Technology & Science
Diploma, Mechanical Engineering
Purdue University
Master of Science - MS, Mechanical Engineering
Kirloskar Highschool & Junior College, Kirloskarwadi
High School, Science and Mathematics
Shivaji University
Bachelor’s Degree, Mechanical Engineering
ABOUT NISHANT HEMANT HAWALDAR
Mechanical Engineer with diversified experience in conventional & advanced manufacturing, process improvement, project management, medical devices, industrial automation, welding, and 3D printing. Experience in supporting existing manufacturing operations through continuous improvement projects and engineering change management. TOOLS & TECHNOLOGIES - Additive Manufacturing: Fused Deposition Modeling (FDM), Binder Jetting, Solid Freeform Fabrication- Design & FEA: AutoCAD, SolidWorks, Onshape, Creo, Ansys- Manufacturing/Fabrication: Sand Casting, CNC Machining, Sheet Metal Fabrication, Soldering- Medical Devices: FDA 21CFR820, ISO 13485, vials (ISO 8362), syringes (ISO 11040-6, ISO 7864, ISO 11608-1), blood tubes (ISO 6710), transport tubes (ISO 6717), and packaging tubs and nests (ISO 11607-1 and ISO 21882)- Welding: Resistance Welding, Gas Tungsten Arc Welding (GTAW), Gas Metal Arc Welding (GMAW)- Robotics: ABB IRC5 Operation & Programming, FANUC M-710iC Disassembly/Reassembly, FANUC Handling Tool Operation & Programming, FANUC ArcTool Operation & Programming- Solar cell: MAXEON solar cells soldering and testing, CIGS solar cells testing- Programmable Logic Controllers (PLCs): Omron Sysmac Studio Logic and Motion Control, Rockwell Control Logix/Studio Design, Maintenance & Troubleshooting - Process Development and Improvement: CAPA, RCA- Lean Methodology: Kaizen, 5S, Poka Yoke, Six Sigma, DMAIC- Quality Management System: Standard Operating Procedure, Work Instruction, Process Specifications, User Requirement Specifications (URS)- Enterprise Resource Planning (ERP): Infor XA, Change Management Software (CMS), SAP Business One, QCBD- ASME Y14.5, DFM, GD & T, MES, PDM Vault, BOM & Router- Adobe Illustrator (Beginner)
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