Eduardo Zepeda Email & Phone Number

Santa Ana, California, United States

● Lead Process Development team to drive project deliverables and train engineers.● Create process development reports to optimize parameters needed to manufacture products.● Perform Design of Experiments (DOE) to understand what factors affect the processes using Minitab.● Collaborate to develop test methods and validate them.● Work with R&D to make changes to design drawings and implement Design for Reliability and Manufacturing (DRM) practices.● Process Capability Analysis to get processes under control using Minitab.● Create fixturing to aid manufacturing, in some cases using basic PLC or timer relays.● Draft and perform IQ/OQ/PQ protocols.● Collect cycle times, line balancing, spaghetti diagrams and process flow.● Work with vendors to outsource simple tedious manufacturing processes.

Irvine, California, United States

● Develop test plans, protocols, scripts, test cases, and reports to fully verify product system level requirements, and regulatory compliance requirements for agency standards such as ISO, IEC, and FDA● Use Application Lifecycle Management systems (DOORS, Helix) to trace requirements, test, and issues of a product’s lifecycle.● Conduct system level software testing, analyze issues, and verify bug fixes● Document, manage and maintain test records consistent with formal verification process and Quality Management System● Build automated test systems based that test product requirements and unit test.● Drive quality into the product development process through analysis and timely feedback of test results to the design teams● Design test cases to include test methodology, test set ups, materials, equipment, test procedure, and requirement acceptance criteria.● Perform Verification activities on class 2 and class 3 medical devices that comply to ISO 10993 and ISO 18562 standards. ● Perform Verification activities for 510(k) clearance of LTV2 Ventilator. ● Learn new product models systems from IP acquisitions and standardize requirements.

Palm Springs, California, United States

● Develop, implement, and manage key performance indicators (KPI) to improve performance of over time. Monitor Operator/Equipment effectiveness, downtime, yield, cost, and throughput.● Lead a team of engineers to increase respiratory ventilator production capacity during COVID-19pandemic. Use Microsoft Projects to create Gannt charts and keep the team on pace to complete all tasks in a timely matter. ● Work directly with Toyota Manufacturing Kaizen Leaders to quickly ramp up medical ventilator production. Hold daily Kaizen events until production ramp up was achieved.● Perform Process Capability (CPK) studies to improve performance of manufacturing test fixtures ● Collect and analyze data and report to performance to executives. Use data to address inefficiencies and take data driven decisions.● Perform Verification activities for new components replacing obsolete (OBS) or end of life (EOL) components to keep production running.● Non-Conforming Product Team Lead (NCR), Corrective Action Preventive Action (CAPA)Investigations, Root Cause Analysis, Supplier Corrective Action Report (SCAR)● Cross-functional collaboration with QA, Materials, R&D, Production and RA to resolve complaints,production yields and non-conforming issues.● Rebranding Project Manager for the transition of CareFusion ventilation products to Vyaire brand● Use Lean Six Sigma methodologies to eliminate waste and defects on the production floor● Create and Execute Engineering Protocols/Reports, Design Validation, Engineering Change Orders(ECO), Engineering Variance Approvals (EVA), Process Validation, Equipment Installation Qualification, Operational Qualification, and Performance Qualification● Provide direction to Manufacturing Technicians/Operators through training● Manufacturing class 2 and class 3 medical devices that comply to ISO 10993 and ISO 18562 standards. ● Use ERP systems to keep track of supply chain issues (SAP, POINTMAN, M2M)

Greater San Diego Area

● Conduct research and develop mathematical models of Benign Tumors converting to Metastatic tumors in the human body.● Model and simulate Breast Cancer development using mathematical models. Finite Elements,MATLAB, C++, Cell Mechanics

Coachella, Ca

● Initiate process improvement projects to increase Biodiesel output.● Develop, implement, and manage key performance indicators (KPI) to improve production of over time. Monitor Equipment effectiveness, downtime, yield, cost, and throughput.● Design and install new systems to improve Biodiesel production, 600 gallons/year to 800 gallons/year● Perform routine calculations (ex. mass balances, energy balances)● Ensure awareness of all health, safety and environmental issues that impact production● Support daily troubleshooting, monitoring, and optimization● Direct contact in bids with vendors to obtain mechanical equipment use develop processing systems. Capital and operating cost estimating and economic analysis.● Program plant for automation; actuators, pressure/temperature sensors, valves, pumps, pH monitor.● Install/wire electrical components, connect sensing equipment to PLCs (Programmable LogicController)● Lead and Provide direction to Plant Operators through training● Problem solve in unexpected situations, Root cause Analysis in a fast pace environment, on call 24/7

Master Of Science - Ms, Bioengineering And Biomedical Engineering

Bachelor'S Degree, Mechanical Engineering

Activities and Societies: Society of Automotive Engineers Society of Hispanic Professional Engineers Theta Tau Professional Engineering.