Ref. No. : CA - 12376 - (Designer & Product Developer – with 16.6 years in Plastic Industry)

Education

M.S in Plastics Engineering from University of Massachusetts, Lowell, MA USA in 2004 - 2006

B.E.in Polymer Engineering from S. J. College of Engineering, Mysore, India in 2000 - 2004

Skill Sets

Green belt expert in Six Sigma Quality Systems.
Lean Manufacturing and Kaizen events
Very strong in statistical tools like DOE, MSA (e.g. Gage R&R), SPC, etc.
Aware of cGMP and US FDA 21 CFR Part 11 and US FDA 21 CFR part 820 rules and regulations
Hands-on experience working on twin-screw and single-screw extruders, and injection molding machines.
FMEA techniques, Control Plans, Data acquisition software
SOLIDWORKS, MOLDFLOW, FLOW 2000, MINITAB, CHARTRUNNER, etc.
Good knowledge of ISO 9001, ISO 13485 quality standards

Work Experience

Technical Manager
Since 2009
Company Profile: Dealers of resins, polymers, chemicals
Job Profile:
Currently working on technology transfer process for manufacturing specialty grade of unsaturated polyester resins
Worked on business development, applications development activities, and designing product specifications
Worked extensively on management of P&L account, products and pricing models for product-line
Used Technical expertise and worked with the customers in understanding their requirements, translating them into suitable products by applying some modifications to suit their tailored needs.
Worked on product yield improvement and reduction of cycle times.
Interacted with customers to provide technical solutions to process/materials related problems and queries
Conducted training programs for production team to enhance the knowledge on products and process to improve their efficiency at work.

Manufacturing/Quality Engineer
January 2008 to March 2009
Company Profile:Global supplier of co-extruded, multi - lumen, braided, thin wall, multi layer tubing.
Job Profile:
Used leadership skills in supervising responsibly overall manufacturing engineering and quality functional activities at Foster West facility.
Was the link between Senior management team at Corporate PolyMedex Group and manufacturing group at Las Vegas facility
Actively participated in capital equipment investment planning by performing feasibility studies and justifying ROI to the senior management
Worked extensively on development of thermoplastics, thermoplastic elastomers, and flouropolymer compounds for critical applications in electronics and healthcare industry.
Worked on applications development and formulation development activities for development projects with the customers (top-tier customers like Boston Scientific, Medtronic, J&J, etc.)
Monitored the process real-time utilizing data acquisition software to ensure process controls were within the validated acceptance limits
Performed Scale up and Process Development activities and Process Qualifications and Validations using statistical tools extensively for New Products Introduction into manufacturing
Worked on decommissioning of equipments and transferring the products to alternate equipment obliging to FDA regulations. Worked with customers to perform Re-Qualifications and Re-Validations ensuring smooth transition
Efficiently handled customer audits (Medical device OEM manufacturers like Boston Scientific, Medtronics, J&J, etc.)
Worked on CAPA reports and SCAR reports to address the non-conformances
Supervised the Quality Control technicians on addressing the day-to-day quality related problems and decision making.
Traveled extensively to visit suppliers for Supplier Quality Audits

Manufacturing Engineer
January 2005 to December 2007
Foster Corporation, PolyMedex Discovery Group
Job Profile:
Worked on guidelines of US FDA 21 CFR Part 11 and Part 820 regulations on Biomaterials innovation and processing technologies for development of biomedical devices - Medical tubing, catheters, stents, body implantables for cardiovascular and neurovascular device
Worked on Hot melt extrusion process for developing drug delivery techniques in Class 100,000 clean-room based on cGMP guidelines.
Developed product-line, Nanopaque® (Next generation materials) targeted for thin-walled medical tubing and bio-medical devices for critical life-saving applications.
Participated and supervised process technicians on trouble-shooting process related problems on day-to-day manufacturing process
Performed Scale-up from R&D to manufacturing process. Performed Process qualification and validations using DOE with Minitab software analysis for new products.
Used Six sigma techniques and achieved overall Cost savings on quality by reducing non-conformances by $200K annually.
Participated in various Lean manufacturing and Kaizen events for systems and process improvement.
Development of Bill of Materials for new products.
Experience working on various polymer testing and characterization techniques e.g. tensile and flexural properties, rheological properties, dynamic mechanical analysis (DMA), DSC, TGA, SEM, EDX, X-ray diffraction studies, etc.

Development Projects:
Development of Next Generation Nano-Radiopaque Filled Polymers for Medical Devices and Applications
(University of Massachusetts Lowell, Foster Corporation Putnam MA)

Profile Die Design for Extruding Window Panel Profile for PVC Polymer using SOLIDWORKS 3D Modeling software and MOLDFLOW simulating modules
(University of Massachusetts Lowell MA)

Study of Effects of Curing Conditions on Mechanical, Rheological, and Physical Properties of Unsaturated Polyester Resins
(SJ College of Engineering, National Aerospace Labs India)

Cost Effective and Optimum Utilization of Raw Materials for Manufacturing Unsaturated Polyester Resins by Recycling Approach
(SJ College of Engineering, Millennium Polymers Pvt Ltd. India)

Skills:
Green belt expert in Six Sigma Quality Systems.
Lean Manufacturing and Kaizen events
Very strong in statistical tools like DOE, MSA (e.g. Gage R&R), SPC, etc.
Aware of cGMP and US FDA 21 CFR Part 11 and US FDA 21 CFR part 820 rules and regulations
Hands-on experience working on twin-screw and single-screw extruders, and injection molding machines.
FMEA techniques, Control Plans, Data acquisition software
SOLIDWORKS, MOLDFLOW, FLOW 2000, MINITAB, CHARTRUNNER, etc.
Good knowledge of ISO 9001, ISO 13485 quality standards

Future Goals

To be a senior manager

Copyright © 2003 - 2015 Smartech Global Solutions Ltd. All rights reserved. Designed by Plastemart.com