COVER LETTER: Please accept the attached Cover Letter and Please Consider the Following, I have spent my career as the driver for meeting goals and directing companies and projects through to on-time commitments. I have been the person responsible for taking the product idea through refinement, structure, and implementation. I have been the person that would carry forward product ideas, change the direction of the operation on a dime, and handle all of the organizational aspects of the business. I know how to form solid Teams of cross-functional members, set objectives, motivate to goals, and meet deadlines. I have been the Manufacturing representative for complex acquisitions, reorganizations, and governmental agency interface, throughout the United States and Europe. Throughout my business career, I have been responsible for the management of manufacturing facilities as diverse as machine shops to Class 1000 clean rooms. I am very comfortable in a manufacturing environment that includes a machine floor, as well as, production that requires a high level of operator assembly in a clean room environment. I have direct experience with injection molding and extrusion operations, electronics assembly, and medical device production. I have been the lead company representative for regulatory inspections (USFDA and ISO Notified Bodies) throughout the World. I have developed, implemented, and managed compliance programs, as well as, changed company cultures to reflect required FDA and ISO compliance guidelines. I have been directly responsible for developing, negotiating, and implementing departmental budgets and have been directly responsible for production planning. I have been directly responsible for Class I, Class II, and Class III medical devices, including developing products from concept through commercialization, moving the products through the FDA/ISO requirements, developing manufacturing operations, and managing the daily activities of the business units developed around the new products. I have implemented 5S programs, Lean Manufacturing, regulatory compliance programs, employee appreciation programs, and vendor audit programs. Each position that I have held has required my constant coordination between manufacturing operations, sales and marketing units, technical support staffs, and corporate management. I am very accustomed to working in highly complex, cross-departmental, matrix companies. You will see in my resume that I have had to begin over a number of times due to business mergers, and acquisitions, which were out of my control. I believe that these career destroying issues have given me a stronger sense of risk management skills and have strengthened my personal development through expansion into business consulting and advanced technology-based product manufacturing. I have always dedicated my days to the projects that I was fortunate to have, while raising a Family. I am now at a point in my life that my children are grown and on their own, and I am looking for the next opportunity to dedicate myself. Sincerely, Jim McGhan

Highlights:

Companies I like:

Medical Device Start-Up

• Manufacturing
• Management
• Surgery
• Financial
• Financial Reporting
• General Surgery
• ISO
• Medical
• Medical Devices
• Training