Summary




Hands-on senior level manufacturing professional with a solid experience in program management, process engineering, operations, quality and regulatory compliance in electronics assembly and medical device industries. Over 10 years experience with SMT and Thru Hole process development and process control at the engineering and management levels. Proven problem solving skills and team building ability. Solid track record of successful experience in optimizing productivity and improving profitability.
Core Competencies Include : Productivity and Cost Reduction Improvements Strategic Planning Change Agent
Forecasting Safety Performance Organizational Development Asset Management
Project Management 6 Sigma 5S Resource Allocation Project Quoting
Organizational Leadership and Development




Achievements

Acceptance Test Supervisor or Quality Engineer
Supervised final quality performance verification of all hardware built on site and submitted for acceptance by government officials .
Stephen T. Scotton , page 4
Associate of Science in Electronics Technology
Delaware Technical and Community College , Newark DE
2 Years of General Business Management course study at The University of Delaware


Employment

2008 -  Present
Engineering Manager

Lead Manufacturing Engineering efforts in support of product replenishment of bone reconstruction devices.
This includes defining kitting operations, packaging and sterilization into reusable surgical trays that are used in typical surgical suites. The recon division is designing innovative state of the art devices requested from consulted surgeons. Lead the manufacturing engineering efforts for definition of product specs, development of manufacturing processes, both internal or at contracted suppliers. Led efforts to mitigate risk to products being developed which include design, materials and process FMEA s. Support ongoing production to ensure seamless order fulfillment.

2006 -  2008
Manager

Coordinated and managed the transition into a new facility. This included planning and executing critical moves of existing manufacturing and production areas and office spaces. Retained original production staffing to accomplish startup operations while meeting customer requirements.

Specified, purchased and constructed a class 10000 cleanroom environment manufacturing space.
Constructed non-cleanroom manufacturing spaces, warehouse and office spaces and loading docks.
Assumed responsibility for all purchasing of all critical materials for building product. Defined and built a non traditional excel based MRP material tracking and trigger mechanism for parts replenishment as the initial material control system while continuing to research the best solution for our needs.

qualified the manufacturing spaces and processes which allowed production samples to be shipped to customers for their qualification and ultimate FDA approval. Product manufacturing started immediately after approval.
Instituted a formal production schedule to drive the production ramp, matching the sales forecast meeting projected requirements, sterilizing specifications. Led effort for material purchasing, incoming inspection and shipping.

2005 -  2006
Director

Managed all production activities for medical life sciences products with staff of 83 employees. Accountable for process improvement activities, quality and regulatory requirements. Managed all product development activities, providing product quotes and initiation of new contracts. Supported all metrology activities.

Increased production by 25% by implementing a defined schedule based on the use of similar materials, minimizing the changeover of parts and equipment.
Reduced scrap by 60% for molded parts supplied for a catheter device.

Worked closely with major customer to develop a process and qualify process support for the launch of a new device. Generated $80K in additional revenue.
Coordinated and implemented a plant move to a different location over a holiday weekend. Critical processes were setup and re-qualified to start on the first workday.
Transferred a major device product line to the customer s Mexico facility. All tooling, documentation, history files, etc. were moved without incident.

Stephen T. Scotton, page 2

2002 -  2005
Senior Manufacturing Engineer

Accountable for product development proposals, scheduling budgets and documentation for devices to be utilized in medical/life science applications. Guided engineering team to ensure projects were completed timely while tracking financial performance as product went from the design phase to production. Defined areas for improved processes for product assembly. Served as Lead Project Engineer for manufacturing design and transfer of electronic and plastic device products into production. Defined and performed product specific qualification and performance analysis of PCBA interface and mechanical enclosures into overall final systems.

Supported manufacturing for developed blood glucose meter. Served as subject matter expert on the circuit board design and manufacture. Transferred production from Germany facility to Mexico.
Led testing efforts for the meter platform as the main engineer, working to understand failures of the meters manufactured. Prepared all reports of progress and fault analysis and provided solutions for corrective actions.
Standardized the file documents allowing for more consistent information into the DHF for regulatory records.
Led efforts in changing facilities. Coordinated the moving of all machinery, office spaces and setup in the new location. Included building certified electronic assembly areas, cleanrooms, machine shop, certified Optics lab and secure warehouse spaces.
Supported manufacturing efforts and scheduling of production builds of contracted developmental device manufacturing and process verifications. Designed and laid out new cell type manufacturing area to increase throughput by consolidating the operation into confined area.

2000 -  2001
Manufacturing Manager

Managed engineering and execution of PCB and box build assembly for high-speed data transmission cable, LAN and telecommunications test equipment. Supervised engineering group charged with maintaining equipment and enhancing existing methods and technologies. Coordinated efforts to enhance assembly processes, planning and material flow to meet technology upgrades and quality requirements for $120M division.

Reduced non-conforming work-in-process from several weeks of inventory cost to 1 day s cost, using root cause problem solving activities.
Eliminated secondary quality inspection by incorporating individual verifications throughout the processes and reducing customer returns by 50%.

Reduced process TAKT time from 6 weeks to 3 by increased quality through process controls and redefining methods of planning activities and resource allocation using lean and Demand Flow techniques.
Increased on-time delivery results from an average of 50% to 95% through the use of lean manufacturing techniques.
Coordinated move to a new facility without impacting customer deliveries.
Managed assembly factory of 3 SMT Lines, 2 Odd form thru hole, wavesolder, ICT and 5 product specific final assembly cells. All assemblies scheduled, built and delivered to specific end user orders. Factory set up to run 7X24

1995 -  2000
Manufacturing Manager

Promoted to manage manufacturing operations for plant with revenue of approximately $400M Customer base was computer technology, medical electronics, data transmission storage and test equipment.

Phased out a high volume customer to an overseas facility and worked to fill capacity with new product/customer requirement without reducing projected revenue stream.
Implemented a traceably utility to track assemblies by serial number throughout factory operations and assembly technologies for new product introduction. Increased sales from an average of $200M to an average of $400M
Worked with major optics based data transmission customer to accommodate integration from subassembly supplier to system integration, box build, full reliability and functional testing of their product allowing complete outsourcing all of their manufacturing with direct shipment to end users.
Supported compliance to ISO, UL and FDA regulations.
Managed SMT, Mixed Technology and box build assembly effort for 12 customers with P and L responsibilities. The factory consisted of 16 SMT lines, 8 wavesolder/thru hole lines and several final assembly cells with some shipping directly to end customers.
Stephen T. Scotton, page 3

Production Manager
Managed electronic technical PCB assembly operation during transition from Apple to SCI ownership SCI purchased Apple Computer while providing direct engineering support to the manufacturing floor. Coordinated and led team of engineers, technicians, operators and supervisors for a 7X24 production effort.

Provided leadership to process and sustain engineering groups on new product introduction and enhancements to technology parts and machines to stay current on industry requirements.

Re-staffed operation during transition from Apple owned to SCI operation. Redefined required training for unskilled labor, implemented positive process controls and quality techniques to minimize rework and material waste while maintaining deliveries to in-plant box build operation.
Manufacturing Process Engineer

Performed process development and implementation of new generation computer assemblies into a high volume electronic assembly operation. Accountable for providing all DFM/DFT feedback into the design cycle, developing processes to accommodate new technology and sustaining activities related to production.

Identified major design flaws and resolution by vendor of SMT placement machined that reduced rework on assemblies by over 50%.
Performed DOE analysis for screen-printing processes to standardize setting and minimize recurring defects due to inaccuracies of setup.

Implemented sided reflow and hand placing of parts on SMT assemblies, reducing product cycle times and additional process steps.
Supported design effort on several key new products, defined new processes, lead proto builds and provided support during product ramp.
Implemented BGA processing as a standard process.

1992 -  1995
Business Unit Team Leader

Engineered and managed self-direct work team in high volume electronics assembly for Southeast Asian Automotive Business Unit.
Implemented all process controls and yield measurements and led problem solving techniques, Kaizan events, Honda Best Practices and mistake proofing.
Drove quality concerns on Toyota products from 50000PPM to 20PPM.
Implemented BGA technology into the process to add process capability for new product introduction.

Racal Communications Rockville, Maryland
Quality Engineering Manager 1992
Supervised efforts to define and implement documentation and controls for compliance to MIL-STD-9858.
Prepared and documented standardized SMT operation, wavesolder and reflow processes.
Implemented a MIL Q 9858 quality system.

1991 -  1992
Quality Manager

Managed quality system and production support group for medium volume SMT assembly factory.

Updated and enhanced all part placement, wavesolder and reflow profiles while initiating a proactive SPC reporting system.

Prepared all documentation and processes that led to ISO 9000 certification.

1986 -  1991
Production Quality Engineer

Supported all quality issues related to production and testing of systems contracted for major military programs built to Mil-Std-9858 requirements, DOE, FMECA, process audits and customer interface.

Education