Medical Device Manufacturing

John C. Burwell ***** Partridge Dr., Lake Oswego, OR 97035 503-***-****

*********@*****.***

PROFESSIONAL PROFILE

Manufacturing operations and engineering professional who is well organized, innovative and a proven team

leader. Demonstrated experience in all aspects of manufacturing operations applying cross functional resources and

quality in a constant product improvement process. Project managing experienced in connecting sales, engineering,

manufacturing, and quality to accomplish the business objectives through unique communication skills.

PROFESSIONAL EXPERIENCE

Frye Electronics – Tigard, OR 1992–Present

VP of Manufacturing / Production Control Manager

Medical Device Manufacturer (Hearing Aid Analyzers, Audiometers, Evoked Potential Device)

• Manufacturing and operations management

o Full manufacturing P&L responsibility. Provide analysis for performance, manufacturing efficiency, trending, and

corrective actions. Create annual budget plans based on historical and future business objectives. Created detailed

reports to expose trends in manufactured and shipped products for presentations at BOD. Created Return On

Investment analysis on capital equipment procurement to ensure increased profitability and process improvements.

Provide business leadership on cost control, profitability and change management.

• Process Development and Management

o Manage complete manufacturing operations from sales order process through product shipment. Structured

manufacturing processes to a pull system with self directed teams following LEAN and JIT techniques to ensure

efficient use to resources. Developed process to control nonconforming product. Created complete performance

indicators for each manufacturing department. Designed database for controlling engineering drawings and

demonstration products. Created a web based Document Control System. Provide detailed verification and

validation of processes, new products and software tools used in manufacturing. Developed design for

manufacturability requirements to facilitate improved throughput with improved product design.

• Provide leadership and managed Quality Management System (QMS) to meet ISO, FDA, and Medical Device Directive

o Managed Customer Complaints System including trending for further Corrective/ Preventative Action (CAPA).

Initiated product changes based on quantitative and qualitative data, design issues driven by CAPA. Reduced

warranty cost by increasing employee engagement in quality system. Implemented CRM process to track customer

communications and connect the support process to the sales department. Create quality objectives to support

device improvements under a constant improvement process with regular cost benefit evaluations.

• Developed employee recruitment, training and retention program.

o Create job descriptions, duties and responsibilities to define position requirements. Create employee pre hire and

growth aptitude tests that align human capital with corporate goals. Develop team leader positions to decentralize

authority in problem resolution at the earliest levels. Managed training database to track employee capabilities,

define future training requirements and track training effectiveness.

• Successful new product introduction and product lifecycle management in all phases of manufacturing operations.

o Provide vital role in new product development based on industry and product serviceability knowledge. Created

complete specification test procedures for all electronic product lines for new product validation and production

work instructions. Provide customer support for operations, failure analysis and remote troubleshooting. Created

complete RMA system to facilitate product tracking with trending for future product improvement opportunities.

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John C. Burwell 15434 Partridge Dr., Lake Oswego, OR 97035 503-***-****

*********@*****.***

Used customer feedback and detailed failure trending analysis to drive new product design. Implemented end of life

project management plans on legacy products as new products are introduced.

• Manage supply chain to meet customer demand.

o Raw material selection and supplier qualification process. Implement complete MRP and accounting system to meet

manufacturing, sales and business requirements. Created bill of materials (BOM), forecasts and capacity levels to

drive inventory control through MRP. Defined specific work in process (WIP) steps to manage production in a pull

manufacturing process. Created unique finished goods storage to reduce inventory levels and increase flexibility to

respond to new customer demands. Reduced delivery time by aligning capacity with requirements.

Fermitek Corporation – Wilsonville, OR 1988-1992

Production Control Manager

A military contract manufacturer

I managed manufacturing group including professional engineers, technicians, assemblers. Developed production standards for

quality and efficiency to drive improvements and cost reductions. I trained personnel to be self-reliant while ensuring goals were met

through measurable metrics. Developed design reports based on specification testing. Worked with engineering to develop various new

products including intercoms, high speed current probes, high voltage power supplies, Xenon Lamp igniters and induction welders.

Created test equipment for use within production. Created milling machine fixtures for production milling machine. Programmed a

CNC milling machine for machine shop department to ensure maximum throughput.

Drake Willoc/ CD Medical – Milwaukee, OR 1984–1988

Senior Electronic Technician

Medical Device Manufacturer (Kidney Dialysis Equipment)

I performed specification testing for kidney dialysis equipment daily. Component level troubleshooting for control circuits and

blood pump monitors. Tested and repaired on a circuit board production line. Part of a JIT/TQC team production environment that set

production standards on efficiency and quality. Quality training developed early in my professional career is the basis for cost efficient

problem resolution at the earliest possible point. I learned the value of self-directed teams through quality training.

Oregon Air National Guard – Portland Airport 1983-1987

Electronic Technician

As a Senior Airman at the Oregon Air Guard, I implemented detailed maintenance and process control techniques. Became

highest level electronic troubleshooting and repair person in my position in cryptographic, PBX telephone and electronic key systems. A

fully qualified 5-level electronic technician. Maintained top secret security clearance. Leadership and troubleshooting skills developed

at Lackland Air Force Base.

Professional Affiliations

Frye Electronics – Board of Directors, 2007-Present

Education

Marylhurst University – Bachelor of Science in Business Management

Portland State University – Electronic Engineering

Portland Community College- Mathematics

US Air Force – Crypto and telephone PBX systems

Computer Experience

Operating Systems: All Windows OS, Linux

Word Processing: Word, WordPro, WordPerfect

Spreadsheet/Financial: Microsoft Excel, Lotus 1-2-3, Quickbooks

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John C. Burwell 15434 Partridge Dr., Lake Oswego, OR 97035 503-***-****

*********@*****.***

Database/Tools: MS Access, Crystal Reports, Paradox, Exact Alliance MFG

Programming: Basic, C/C++, Labview 8.0

Graphics/Engineering: Photoshop Elements, PCAD, Autocad, Circuit Maker 2000

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