Apr 2022 – Present · 3 yrs 11 mos · Buffalo Grove, Illinois, United States · On-site

• Project Management:
• > Driven the Scheduling, planning, execution, and implementation of over 200+ Engineering improvement projects (ECO’s) on automation assembly lines which resulted in 40% OEE increase over the course of commercialization of 85-million-unit per year inventory ramp up by using waterfall and agile project management methodologies.
• > Led and executed, with the CFT, 10 major kaizen projects and several Small Group Activities and achieved a combined operating profit of $ 242,108 per month and soft savings of $ 1 Million across 2 automation factories; Factory scrap was reduced from 6% to 1.3%.
• > Spearheaded line validation and production readiness activities to support IQ/OQ/PQ requirements for 3 highly automated assembly lines with in a 1.5-year timeline; achieved production capacity worth 33 million units /line/ year.
• New Product Introduction (NPI):
• > Championed the NPI Launch of 11 distinct product variants for Class 3 medical devices possessing new and updated glucose monitoring technology for Type 1 and 2 diabetes patients
• > Supervised 50+ NPI Engineering trial runs and 90 sustaining projects with the CFT, resulting in streamlined operations and improved efficiency in a medical device manufacturing plant.
• Program Development:
• > Managed 15+ claims and negotiations with the customer on machine, supplier quality, E&O and vendor issues and generated revenue of $ 260,000 through Cost/Benefit analysis
• > Coordinated 18 SKU setup matrices in the assembly lines, one for each shipping region, in reference to the demand and forecast planning. Created daily build and product release projections.
• > Maintained 10/10 monthly customer scorecard since the past 1.5 years for Process capabilities, Pre/Post shipment product quality, on-time product delivery and viewpoint survey.
• > Managed 5 Program management assistants as direct reports and coached them to drive daily, weekly, and Ad Hoc CFT meetings to achieve the KPI metrics and project timelines

Apr 2019 – Apr 2022 · 3 yrs · Buffalo Grove, Illinois, United States · On-site

• Manufacturing Engineer (Cross functional team Lead):
• Business process setup and improvements:
• > Instrumental in developing the User requirement specification for the business IT process to enable end-to-end factory wide manufacturing execution system (MES) for ease of material flow of 67 components using 15 IT applications in conjunction with ERP system.
• > The modules in the business setup include Shelf-life sensitive inventory, customer forecast, commit, build plan, build schedule, scrap management, purchasing, receiving, warehousing, automation assembly, shipping and overall inventory control using software and communications interfaces.
• > Sole Business point of contact for review and approval of over 400+ software validation documents executed by IT/ supply chain teams (FRS, FRA, Design specification, code logic review, SIQ, Test case execution, summary report reviews etc.,)
• > Driven the material scrap reduction of $120,000 per month by implementing a scrap data collection methodology and involving the CFT to tackle top scrap detractors
• > Implemented 40+ Standard operating procedures (SOP) and demonstration of effectiveness (DOE) documents for manufacturing personnel
• Product Quality development:
• > Managed the cross functional team on the timely bracketing, containment, disposition, and closure of 166 Non-conformances (NC) against product and process quality defects
• > NC cases include supplier quality defects, Line maintenance and calibration conflicts, DHR documentation failure, cleanroom contamination and excursion, product lot traceability errors, Eng. material escape, product expiration issues, vision system issues and product assembly damage.
• > Reduced the number of NCs from 12/month to zero, maintaining a track record of No non-conformances since past 5+ months
• > Worked with the CFT to Implemented subsequent CAPAs for each case of NC and monitored with regular intervals of pFMEA analysis, statistical process control and risk management techniques.