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Power Packaging

Manufacturing Engineer 2, MDR, Teleflex

October 2021- Present

  • Evaluating current manufacturing practices across 5 product lines and conducting a process validation gap analysis

  • Adding additional controls in the PFMEA for processes with high RPNs to reduce nonconformances and rework

  • Assisting sustaining activities by configuring BOM on Oracle Agile and making labels on BarTender of class III products

  • Developing controls for the packaging of the intra-aortic balloon pump (IABP) class I device as per EUMDR requirements

  • Leading a six-sigma initiative to improve IAB catheter yield by 50 % by correcting leading causes of scrap based on a Pareto analysis

  • Validating new equipment (IQ/OQ/PQ/TMV) to assist with lean manufacturing projects and improve throughput by 25 %

  • Training 2 new process development engineers to the existing process validation SOP and data sampling SOP

Contract Manufacturing Engineer, Zimmer Biomet

December 2020 - October 2021

  • Remediated routings and BOM on Infor XA using a Change Management System as part of a site wide cleaning validation

  • Grouped routers based on common high risk work center flow reducing total cleaning validations required by 30%

  • Updated work instructions and inspection criteria following 21 CFR 820 and ISO 13485 in a medical device manufacturing company

  • Worked cross functionally with the Quality, Regulatory Affairs and Operations teams to streamline the strategy for updating routers

  • Served as the MS Excel SME to assist a team of over 30 engineers to increase the number of routing updates per week by 20 %

Team Leader - Organizational Performance Measurement, CPULD

January 2020 - May 2020

  • Collaborated with a team of 4 members and the Director of CPULD to develop KPIs to measure critical business processes

  • Mapped KPIs with the SIPOC to identify metrics to cover all perspectives of organizational performance in the research lab

  • Developed a survey and conducted multivariate analysis on the responses on R-Studio and SPSS to gauge employee satisfaction

Project Management & Automotive Quality Data Analyst Intern, Micron Technology

September 2019 - December 2019

  • Drove continuous improvement projects in the cleanroom fab compliant with Good Manufacturing Practices (GMP) and ISO 9001

  • Visualized project metrics and Gantt chart timelines on Tableau Dashboards for all the team projects to track project progression

  • Drilled down into fab debris reports using ad hoc data analysis on Tableau Dashboards to develop cause and effect diagrams

  • Slashed fab debris from 3 pounds to 1 pound/week by conducting internal quality audits to identify weekly trends in debris

  • Facilitated cross-functional communication between area supervisors by publishing project scorecards on SharePoint

Production Intern, Power Packaging

June 2019 - August 2019

  • Optimized manufacturing and supply chain processes complaint with FDA and SQF level 3 in a food manufacturing environment

  • Implemented corrective actions based on SPC charts and Cp / CpK studies on Minitab slashing costs by $121,000 per year

  • Spearheaded a lean manufacturing and time study project to reduce the inventory and cycle time achieving savings of $160,000/year

  • Developed technical documents and visual aid checklists based on weight specification to reduce overfilling food powder

Production Planning & Control Intern, Fine Jewellery Manufacturing Limited

June 2017 - September 2017

  • Incorporated cellular manufacturing and relocated workers to increase worker productivity by more than 4%

  • Analyzed and improved Critical to Quality (CTQ) metrics using the DMAIC cycle decreasing gold loss by 5%

Work Experience: CV

©2020 by Niket Sura

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