Engineer Project

STEVEN B. SHANNON

*** ******** **., ****** **. **934

302-***-**** / *******@*****.***

Senior Manufacturing Engineer

Overall Experience

Over my career I have transferred Catheters, Disposable Medical Electronic Devices products, medical analytical test equipment, and Dental Products from Development into Manufacturing. I have developed, implemented and qualified new product and equipment processes using IQ, OQ, and PQ Validations. I have performed product and process problem solving using Root Cause Analysis, DOE, and SPC tools. Developed component & assembly specifications and bills of material in an ISO/ FDA GMP design and document control environment. Implemented cost reductions, process improvements, and maintained product compliance for CE marked products, set up process flow and wrote assembly and test procedures. Trained and evaluated assembly operators in manufacturing operations. Developed project schedules and kept team members on tasks to meet implementation dates. Wrote Capital Expenditures and control project budget spending against the project budget.

Career History

Job Descriptions

Introduced new products into production, including developing and purchasing equipment, production startup, Facilities layout, process and equipment IQ, OQ, and PQ validations. Implemented cost reductions, process improvements, participated in MRB, compliance to ISO 9000 and maintaining requirements for CE mark, setting up process flow and writing assembly procedures. Trained operators on equipment and assembly operations and instructed engineering technicians on line support responsibilities. Wrote RCEs and controlled budget spending against RCE. Implemented a plan of action to meet scheduled implementation date and reviewed project status and accomplishments to operations management.

Developed and maintained productions labor standards and capacities for all new and existing manufacturing filling and packaging operations. Ensured all equipment and tooling are properly documented and under calibration and preventative maintenance control as required. Performed FMEA activities to ensure process shortcomings are identified and appropriately addressed. Used Lean Manufacturing principles, Kaizen events and 5S techniques to continuously improve production efficiency, safety, and product quality. Established data collection criteria, ensured proper training, and evaluated trend data for improving process capability. Wrote Capital Appropriation Requests and stewarded projects to meet or exceed objectives, cost and schedule. Planned projects, identified processing requirements, and overall project schedule.

Contract Packaging Engineer, Aphena Pharma Solutions, Nov 2011 – April 2012

Highlighted Successes

• Setup and Qualified bulk liquid medical and pharmaceutical products lines into production. Including IQ, OQ, and PQ validations.

• Developed SOP and Work Instructions.

Senior Production Engineer, Dentsply Caulk, Oct 2005 – Oct 2011

Highlighted Successes

• Setup and Qualified bulk powder, paste and liquid medical and pharmaceutical products lines into production. Including IQ, OQ, and PQ validations.

• Qualified a formula modification in the NUPRO® Sensodyne® Prophylaxis Paste and qualified the Tiromat filling equipment using a new Fill Head.

• Qualified the manufacturing and filling operations of a new wax based and glycerin based Prophylaxis Paste. Including a cleaning validation of the multi-use filling system.

• Qualified filling system to fill and vacuum plug Self Adhesive cement into Digit cartridges and Double Barrel Syringes.

• Qualified new multi-process equipment that included compule auto loading, filling, inspection, and capping operations.

• Team Leader for a scrap reduction project that saved $107,000 annually by reformulating a paste to reduce the amount of diamond in the paste, Eliminated redundant testing, improved equipment setup and process standardized work practices.

Steven Shannon, Page Two

Senior Manufacturing Engineer, Abbott Laboratory / Hospira, 1985– 2005

Highlighted Successes

• Project team leader for the product transfer and line support of CCO Catheter, which included 48 unique assembly operations such as hydrogen welding, catheter tip forming, insert molding, centimeter band printing, leak and flow testing, heater coil assembly and testing, urethane coating application and curing, packaging, and assorted manual assembly operations for a 600/day assembly operation. Developed assembly processes and qualified semi-automated equipment that improved process yield and thru put that reduced the Continuous Cardiac Output Catheter cost by $35.00.

• Developed and qualified new RF catheter tip forming operation for the Thermodilution Catheter that improved catheter tipping yields from 70% to 92% and reduced manufacturing processing time by 25%.

• Qualified an automatic tubing assembly machine that assembled 23 different tubing assemblies. The machine operations included tubing cutting, tubing labeling, coiling and solvent bonding operations with a Stopcock or Female Luer. This machine increased tubing assembly by 400% and eliminated three operators.

• Developed and qualified a Centimeter band pad-transfer printing process for the Continuous Cardiac Output and Opticath Catheters that improved centimeter bands quality and eliminated rework touch-up steps.

• Qualified new Urethane adhesive coating material for Continuous Cardiac Output Catheter heater coil that reduced adhesive curing time from 48-hour to less than 1-hour cure.

• Supported development and assembly line support on Transpac II, III, and IV blood pressure transducers.

• Reduced Disposable Blood Pressure Transducer Cost by 50% and supported increased Blood Pressure Transducer market share from 12% to over 60% within 4 years.

• Developed and qualified Hybrid circuit and setup Thickfilm processing operation that reduced Transpac II Compensation Circuit from $1.18 to $0.12.

• Developed and qualified Thru-hole Hybrid circuit design that further reduced size and cost of TPIV Blood Pressure Transducer.

• Qualified Semi-automatic die down, Automatic wire bonding, Laser trimming, and assorted manual assembly operations for a 30,000 unit/day operation.

• Worked with Motorola to qualify an all on-board resistor chip design for the TPIV Blood Pressure Transducer that created a low cost pressure sensor assembly.

• Redesigned electrical connector for the TPIV Blood Pressure Transducer to eliminate customer service related intermittent failures. Incorporated the connector into a $1.2 MM automatic cable assembly machine. U.S. Patent: 6,010,371 was issued on January 4, 2000 for this design.

• Assisted hospital technicians in compatibility testing of TPII and TPIV Blood Pressure Transducers with Hospital Monitors.

Education and Continuing Education

BS, Manufacturing Engineering, California Polytechnic University Pomona, Ca.

AS, Technical Drafting, Mount San Antonio College Walnut, Ca.

Continuing Education

Lean Manufacturing, PDCA, Kaizen, 5S, AAMI Design Control Requirements & Industry Practice, AMMI Process Validation Requirements & Industry Practice, How to apply Potential Failure Mode and Effects Analysis by Eden H.C.Chen,Ph.D. FMEA Institute, Weber State College Statistical Process Control, Statistical Programs for Variation Research, Statistical Design of Experiments, Weber State College Design of Experiments, Solid Works 2001, AdvantEdge Problem Solving & Decision Making, Microsoft Project , and Pathwise Project Success Project Management.

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