Knowledgeable Senior Manufacturing Engineer with 25 years of dedicated experience in manufacturing and project management. Accomplished at implementing new products/projects and leading by example. Committed to efficiency through continuous improvement projects.
- CGMP
- FDA 21CFR 820
- ISO 13485:2016
- ISO 9001:2015
- AUTOCAD
- Lean Black Belt
- Six Sigma
- Project Management
- Start-up Productions
- Budget/Proposal Preparation
Omaha, NE, 10/2004 - Current
Provide engineering support for manufacturing operation. Develop system requirements and recommendations for new process and new manufacturing equipment. Analyze production processes and develop streamlined strategies to maximize efficiency. Support and execute equipment qualifications to meet cGMP requirement and satisfy FDA and ISO regulations.
- Devised, evaluated, implemented multiple automated filling equipment projects. Researched and proposed equipment. Managed capital request and cost justification. Interfaced with equipment vendors during design reviews. Designed equipment layout and orchestrated the installation of the equipment. Developed and executed validation protocols as necessary (Factory Acceptance Test, Design Qualification, Installation Qualification, Operational Qualification, Performance/Process Qualification). Addressed / resolved issues during validation and issued final summary reports. Oversaw a capacity ramp-up project with new automated line for vial filling and capping that generated cost savings of > $100k.
- Key member of cross-functional teams to support production transfer of Quantiferon TB tests, Lateral Flow Test Strips, Life Science products, Covid-19 test solutions, and NeuMoDx products. Contributed in researching and installing equipment for new processes, training operators, capacity planning, and in creating manufacturing documentation.
- Certified Six Sigma and Black Belt Lean Manufacturing (2015). Responsible for driving process and equipment improvements by coaching kaizen projects. Also assisted in training other employees for yellow belt and green belt certifications.
- Supervised Equipment Maintenance Team (2012-2015) and achieved goal of less than 5% equipment downtime.
- Instituted real time reporting and analysis tools to monitor/track Overall Equipment Effectiveness (OEE).
- Serve as technical resources for daily support of manufacturing operations. Troubleshoot equipment as required. Create and maintain Standard Operating Procedure for various manufacturing equipment.
- Generate Engineering Change to track and document new process and process improvements projects for automated and manual filling lines.
- Recipient of Project Award, 2006, 2007, 2008, 2011, 2014, 2016, 2020.
Douglas, AZ, 2001 - 2003
Launched an advanced manufacturing engineering program. Formed a technical team of 20 technology experts to produce high-quality, quick turnaround prototypes. Administered a $1.5 million annual project budget.
- Managed all funding and installation for a complex printed circuit board assembly line.
- Collaborated with design engineers throughout New Products Introduction lifecycles and in development of new process technologies. Conducted cost analysis evaluations of new processes/ products.
- Supported initial production launch to outside vendors. Saved over $850,000 in pricing negotiation.
Wayland, MA, 1998 - 2000
Directed a fully automated production line for radio base station that generated up to $16 million in monthly revenue. Formed a factory team of 180 personnel in a three-shift operation.
- Managed a $9 million capital investment successfully for a fully automated production line of radio base station products. Increased monthly production throughput to 45,000 from 8,000 units, reduced production cost 40%, production fault rates 15% and quality workmanship failure 11%.
- Built a close working relationship with the business units in Sweden and Brazil relating to forecasting, master scheduling, supply chain management, order acknowledgement and warehousing.
- Recipient of Special Recognition/Retention Program and Leadership Incentive Plan Awards, 1999.
Sarasota, FL, 1996 - 1998
Developed strategic plans for departmental growth and resource allocation. Served as a technical advisor. Tasked with research of emerging technologies and tools to enhance quality and manufacturing processes.
- Directed a process improvement project team. Achieved a significant reduction in production lead time, an 80% decrease in work-in-process inventory, a 60% reduction in labor and a 10% increase in process quality through automation, lean manufacturing, and design for manufacturing/assembly.
- Recipient of an Ericsson Management Award, 1998.
City, STATE, 1993 - 1995
Provided engineering support for printed circuit board and final assembly lines for private radio and cellular base station products. Instituted labor standards and production routings. Trained operators. Documented processes in compliance with ISO 9001 requirements.
- Orchestrated the transfer of new products from Sweden to Virginia. Authored and presented project reports to the management, hosted planning meetings and facilitated interactions among production and engineering functions. Achieved 100% delivery performance.
- Served as member of a cross-functional team for deployment of new MRP systems.
- Participated in Design for Manufacturing reviews and pilot production for several new products.
- Recipient of Ericsson Merit Shares Awards, 1994.
City, STATE, 1991 - 1993
Instituted labor standards, layouts and cost estimates for new products. Analyzed and implemented cost reduction initiatives. Supervised a material specialist in managing bill of materials and product routing on MRP systems.
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School Attended
- Texas A&M University
Job Titles Held:
- Senior Manufacturing Engineer
- Manager II - Manufacturing Engineering
- Manager II - Production
- Senior Technical Lead
- Manufacturing /Industrial Engineer
- Industrial Engineer
Degrees
- Master of Science and Bachelor of Science
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