SUMMARY: Led doubling of business for LSR Injection Molding Factory by developing all corporate engineering & operations functions. Transitioned to Head of Operations to improve organizational teamwork & efficiency while reducing scrap and ensuring on time, in full, and in-spec delivery to customers.Responsible for transforming our current manufacturing facility of custom molded Liquid Silicone Rubber (LSR) Two-Shot LSR-Thermoplastic and LSR-Multi-Shot solutions into a highly productive and efficient operation. This role involves leading and overseeing the Production, Process Engineering, Tooling, Maintenance, and Supply Chain departments to drive continuous improvement, operational excellence, and optimal utilization of resources.• Restructured organization to optimize decision-making and technical problem solving leading to improved output with as much as 20% decrease in scrap and 15% reduction in company headcount.• Focusing heavily on cost reduction (labor, scrap, rework) while participating in growing top line with marketing through technical leadership (Conventions & Customer visits).

• Facilitated acquisition and launch of key major medical device customers i.e., J&J, Alcon, Abbott, and automotive customers i.e., TE, Valeo (2019 ~12M sales to 2023 ~$25M.). Developed/maintained corporate Cost of Poor Quality.• Developed, implemented, and managed a corporate Quality Management Strategy (QMS) to help transform the company into a data-driven organization with recognized customer service.• Leveraged corporate ERP System (IQMS) and HTML dashboards to improve data acquisition & analysis.• Ensured corporate QMS and regulatory compliance with ISO 13485, ISO 9001, and IATF 16949 to meet multi-industry customer needs in Medical Device, Automotive, and Consumer Goods markets.

* Instructed IE462 Lean Six Sigma, Quality, and Process Improvement at Southern Illinois University Edwardsville. Prepared Lectures, Homework, Quizzes, and Exams for class of 40 seniors in Industrial Engineering. Emphasized the Lean Six Sigma DMAIC problem solving techniques, including Quality Tools, Statistical Process Control, and DOE.* Rated 4.5/5.0 on teaching skills by class of 34 undergraduate and graduate students.

SUMMARY: Managed Manufacturing Operations Quality for fast-moving consumer goods.* Ensure Product Quality through Control Plans and Training.* Ensure Global Manufacturing Quality Manual implementation and maintenance: practice GMPs in order to improve and sustain quality standards that will reduce risk.* Implement Change Control: In support of both new product/process, current product/process sustain and update. Ensure implementation with proper success criteria* Ensure and enhance Consumer Experience (Shelf & Home use): Measure and respond to measurement of Store Check Shelf Appearance and home use Product Performance Consumer Feedback.* Operations Departments support: Providing constant support to the operations manufacturing lines, in order to keep production a) Safe, b) with Quality, and c) Output. Support identifying root causes of problems; coaching operations team on how to develop their own assessments, actions and reports; and leading communication and actions related to Suppliers issues.

SUMMARY: Performed quality engineering on current and next-generation drug delivery devices.• Establish new Product/Process Qualification SOP, Design for Manufacture (DFM), and Design for Quality methods to lead cross-site design transition from overseas NPD (Europe) to Manufacture (US).• Generate Process FMEA assessment & documentation for all Manufacturing & Service processes across the organization by conducting cross-functional reviews. Ensure compliance with ISO 13485:2016 (leveraging ISO 14971:2007 and IEC 61812: 2006 as guidance). Integrate into Risk Management File for device and Risk Assessment & Report.• Maintain & Improve Medical Device Manufacture & Device Service Quality Systems at Device Manufacture and Device Service sites (Worldwide Internal & Contract) through involvement with SOP and WI creation for Design, Manufacture. Ensure alignment with ISO 13485:2016 directives and enterprise business goals.• Improve business decision making & agility through quality data analysis, process improvement, and documentation (SOP/WI) including automation/streamlining of SAP Workflows & analytical reporting. Enhance efficacy of NCMR. MRB, and CAPA closure activities through participation, leadership, and data-driven decision making.• Go to resource for Root Cause Investigation in Design, Sustaining, Manufacture Engineering as well as through Customer Service. Implement Technical Problem Solving, Design of Experiment, Reliability Test Methods, and effective report documentation. Drive any CAPA/CC needs to closure.

SUMMARY: Lab manager for Quality and Reliability Labs serving power tool design, manufacture, and warranty.*Provide leadership and training to team of 5 engineers & 8 technicians supporting NPD metrology development, manufacturing metrology execution, and customer return/warranty analysis.*Refocus Q&R organization by prioritizing value add Quality Metrology and Reliability Analysis deliverables.*Establish new Product/Process Qualification Methodology to improve transition from NPD to Manufacture.*Strengthen Warranty Mgmt. by improved Root Cause Analysis, data capture/metrics, and alignment with QMS.*Form global lab network, developing Lab Request System database and enterprise level data collection across sites.*Develop Metrology Roadmap based on prioritized deliverable needs and align with Capital Equipment Planning.

SUMMARY: Lab manager hired to develop Q&R Lab for test & measure of NPD security product design, mfg.*Developed “Q&R Validation” business system including process mapping, documentation, and training. Worked across orgs to integrate marketing/user requirements, engineering specifications, and quality test plan data.*Led team of 3 engineers & 3 technicians to efficiently deliver data to an NPD organization, transitioning test lab from passive data collection to Reliability Engineering Analysis (DOE) and Regulatory Compliance Testing (UL, FCC, IEC). Expanded performance testing to include environmental durability, automated cyclic fatigue, electronic characterization, and dimensional metrology. Improved test resolution and ensured effective documentation.*Designed and implemented custom Quality-Reliability Database (Delphi-Access) leveraging Enterprise Management Software (ERP) and real-time input of test/measurement data; queryable for KPI & product analysis.*Formed and led enterprise-wide Q&R lab network to support NPD engineering, manufacturing, customer service.

SUMMARY: Primary contact & floor supervisor for Quality Engineering of high-volume precision MFG components.*Developed NPI Manufacturing Validation Plan for timely production of precision alloy components for medical device, electronic, and automotive customers. Ensured compliance to customer and regulatory specification. (ISO13485, TS16949, ISO9001). (NPD cycle time 1-6 months, multiple NPD projects simultaneously)*Developed and executed methodologies for In-Line Manufacturing Statistical Process Control and Reporting, highly dependent on ANSI Y14.5 GD&T & Automated Inspection System programming in high volume environ.* Led an effort to create Validation Processes that included Control Plans, FMEA, Capability Studies, Metrology Capability Analysis (GR&R + Stability), and Inspection Work Instructions.*Analyzed/reported results with statistical software tools (Minitab, JMP).*Led gage calibration and metrology development, including dimensional analysis with Touch Probe and Vision CMMs (Mitutoyo & OGP), hard gage measurement, surface roughness, and hardness testing.

SUMMARY: Primary contact turned Ops Mgr of next generation PCB product development, test, and validation.*Designed & implemented Quality Management System for ISO9001; including documented business processes for NCR-MRB, CAPA, Quality KPI metrics (Capacity, Takt, Yield)*Led development of custom IT solution for work request & data entry (Global Analysis Information System)*Provided leadership to a growing team (8-16 technicians) in both PCB manufacturing line and failure analysis lab to improve efficiency, teamwork, and output quality. Implemented Lean-6S processes to maximize efficiency in lab business processes. Utilized KPI’s and Intel Performance Management System to advance individual skills.*Engineering support for Q&R Analysis and Root Cause Investigation. Supported x-function team to design accelerated life tests and model/analyze fatigue and failure modes. *Instrumental analysis: Cross Section and Dye Penetrant Analysis, SEM + EDS, TMA, DSC, FTIR, electrical FI, & more.*Independently developed and delivered custom Automated Inspection System using Clemex Image recognition software and precision mechanized staging to efficiently.

• Engineering support for Quality and Reliability Analysis and Fundamental Materials Investigations primarily in the System-Level Printed Circuit Board Manufacture and Electronic Packaging side of business. Worked closely with cross functional design team to design accelerated life tests, and model/analyze fatigue and failure modes. • Collected and analyzed product performance data and conducted root cause investigation using a host of tools, including: Cross Section and Dye Penetrant Analysis, SEM + EDS, TMA, DMA, DSC, FTIR, Optical Measurement Methods, electrical fault isolation and more.• Independently developed and delivered custom Automated Inspection System using Clemex Image recognition software and precision mechanized staging to efficiently.