Reporting to the Senior VP of OperationsResponsible for entire plant Manufacturing Operation, Incoming Quality, In-process Quality and Final Test for Class II medical device / cosmetic laser with $150 million in sales and a staff of 40+. Areas of focus: lean manufacturing implementation, manufacturing capacity planning, departmental budgets, manufacturing planning / scheduling, customer shipping commitments, cost, labor, inventory process control improvements and quality / productivity metrics coordination / regulatory compliance. ISO13485 and FDA readiness.Created and maintained systems to measure key performance metrics (On Time Delivery, First Pass Yield, Manufacturing Efficiencies, Production Output, Production Throughput, WIP Value, etc.), Consistently under spending budgets. Lead a cross functional team that converted large portion of supply chain to a Kanban Pull system. Implemented “Lean One Piece Flow” on 6 of 12 major product lines, Improved ISO Audit findings from 31 major findings to 3 minor observations in first 2 years. The following is an excerpt from our VP of QA/RA: “Both ISO auditors noted that the MFG and Materials areas looked the best they have ever seen in 10+ years of auditing our facility.”, Successfully implemented Kanban system for all manufacturing “sub-assembly make” parts, Improved “On-Time Delivery to customers from 58% to 98%, Improved manufacturing efficiency by 25% in first quarter of overseeing manufacturing. Lead Incoming Inspection Department, reduced cycle time of material throughput by 50%, Designed Training Matrix for entire operations group identifying “training vulnerabilities” and opportunities to improve diversity for job flexing, Introduced cross-functional operations meetings between manufacturing, customer service and materials groups, Wrote Quality System SOPs greatly improving compliance to ISO 13485 and FDA regulations, Coached and mentored manufacturing staff of 40+ improving morale, involvement and attitude.

A brief but "fruitful" stint at manufacturer of printed flexible cables and circuits. Managed materials department creating cycle count program and kanban program.

Reported directly to the Plant Manager. Responsible for entire plant manufacturing operation for Class III medical device manufacturer with $50 million in sales and a staff of 50+ including engineers, associate managers, supervisors and group leads. Areas of focus: creation and management of budgets to $10 million; manufacturing business and capacity planning (working interdepartmentally); cost, labor, and inventory process control improvements; ECO board, Safety and Cost Improvement team service/leadership, and Quality Metrics coordination. Selected Initiatives / Exemplary Performance Highlights: Recognized by company for achieving high quality amidst strong departmental growth while consistently controlling and coming in under departmental spending budgets, Recognized for achieving zero non-conformities in all Operations Departments managed through monthly internal compliance audit processes, ISO 13485 audits, Represented MFG group in the successful implementation of Lean Manufacturing techniques for disposables lines, resulting in 40% reduction in work space, 25% reduction in WIP, 50% in scrap/rework, and 25% reduction in cycle time, Organized the start up of the IAB disposables line in 1999; took over responsibility for a second disposables line in 2000, and improved line efficiency by 50% in six months, Assumed management of IABP line (Capital Equip) in 2005 improving efficiencies to 95% from 73%, Developed “Activity Metrics” with cost accounting group which resulted in systemic management of direct labor, required production output, and required standard hours, Developed a labor reporting improvement program which significantly reduced labor variances, Designed and implemented SPC program which identified and eliminated ‘out of control’ processes on the disposables line, Lead a “Compliance Awareness” GMP training program for the manufacturing, quality, materials and engineering departments.

Class III Medical Device Manufacturer of Cardiac Aortic Balloon Catheters in a clean room environment. Managed staff of 30+ in the assembly, test, pkg and labeling of a class III device. Consistently met customer demand and corporate build forecasts, while under budget and at or above target labor efficiency goals. Assisted in layout of factory floor to allow for maximum efficiency and flow. WIP tracking, inventory reduction efforts, yield improvement teams, scrap reduction, SPC implementation.

A small start-up med device company that introduced a class III disposable cardiac catheter. Responsible for overseeing (hands on) the assembly of prototype and sellable product in a cleanroom environment. Included quality control, DHRs, final testing and packaging. Wore many hats in this young startup including the building of a staff (hiring, interviewing, etc.).