Nitin Sood Email & Phone Number

Minneapolis, MN, US

Minneapolis, MN, US

Gothenburg, SE

• Owner of melt extrusion line & responsible for production of single lumen PET balloon tubes and multi-lumen catheter shafts sub-assemblies to support manufacturing of peripheral stent delivery system
• Led engineering team to commission a new capital extruder equipment ~ $650K without impacting schedule, cost and met project deliverables
• Managed equipment calibrations, PM’s, part inventory, fabrication of tooling, dies and mandrels and its qualification
• Lead MFG engineering MRB meetings to investigate NCR’s, Root cause analysis and disposition of non-compliant product by providing appropriate engineering justification
• Validated new extrusion line via IQ/OQ/PQ process that included authoring qualification documentation in compliance with companies quality system adhering to ISO13485; 9001:2003 and 21 CFR 820
• Contributed towards creation of PFEMCA, DFMECA / updates, CAPA investigations & FDA audit preparedness

Burlington, MA, US

• Technical team member - supported release to manufactruing of 50L,2000L disposable bioreactor launched in 2012 & 2015 and EMD Millipore’s Pureflex plus® multilayer biopharmaceuticals film launched in 2014
• Contributed to cost reduction of 2D bag making process leading to an annual savings of ~ $190K
• Led polymer evaluation process by implementing test regime for tensile, creep and ECSR properties
• Collaborated with vendors to fabricate molded components to support ongoing PDP project deliverables
• Developed disposable plastic components and sub-assemblies for cell culture and pharmaceutical applications and led IQ/OQ/PQ process validation to meet project milestones
• Design reviews with FMEA, FAT, DoE’s, notebook studies, GR&R, Cpk & Ppk, CAPA investigation

Burnaby, B.C., CA

- Developed, executed & monitored ink coating trials of carbon fiber substrates for PEM fuel cells- Tested and prototyped MEA fuel cell stacks of gas diffusion layer materials for performance evaluation- Performed experiments to study rheology, shelf life and mixing of micro porous layer inks

Carlsbad, California, US

-Implemented process flow diagrams to manage tooling and it's maintenance. Worked with OEM to replace old tooling with improved extrusion tooling to retrofit the existing machine which resulted in quicker switch-overs. Also aided in qualification of the tooling by documented engineering studies prior to releasing it to production floor. -Contributed in.

Woburn, Massachusetts, US

Worked on biodegradable plastics which was an ongoing research project of Mextabolix, Inc. Performed engineering trials on equipment's that included injection molding, twin and single extrusion compounding, film extrusion and tested specimens for mechanical and rheological properties for PHB/PHA/PLA bio-degradable materials involving complex formulations..

M.S., Plastics Engineering

B.S., Mechanical Engineering