Tim O'Brien Email and Phone Number

Integrate into production new or modified manufacturing processes, systems, or designs of Medical Devices. Includes IQ/OQ/PQ protocol generation, performance, report and final implementation. Design engineering systems for the automation of assembly of complex medical devices. Define processes and analyze labor costs to determine if automation has the capability to provide an ROI of less than one year.  Completed comprehensive Capitol Equipment Requests (CER) which included yearly profit for specific area, existing yearly labor costs, cost estimate of designing, manufacturing, debug, installation and validation of new plant floor equipment. Validation responsibilities included generation, execution and final signed reports of IQ/OQ/PQ protocols. Designed electrical/software systems that included GE, Horner, Keyence, and PC based control systems. Languages used included Ladder Logic and Visual Basic .NET for machine, motion laser, and temperature control. Lead initiative to take the Design Automation group from being just an internal automation equipment supplier to being a full service resource that included cost analysis of labor intensive processes, product flow across different departments, cost estimate generation with ROI, Validation Protocol generation during the design /build phase in order to capture all the requirements of the automation process.  Implementation of Six Sigma DMAIC tools as needed to accomplish above responsibilities.

Implemented a major advancement of Laser Technologies within the Chaska campus. Purchased $2 million plus in laser technology for use in the ablation, marking and welding of medical devices. Responsible for all Laser Technology from 2005 to 2008. Responsible for the Advanced Device Manufacturing (ADM) department for over six (6) years. This area included the production of the Enterprise Neurological Stent and Angioguard blood filtering system. Extensive use of Six Sigma DMAIC tools were used to drop scrap by over 80% and cut the labor cost of the enterprise stent manufacturing by over 50%. Estimated savings of over $2M per year. Led Team that created PFMEA’s for multiple (5+) product lines in the ADM department. Generated, performed and reported on full validations (IQ/OQ/PQ) for individual processes on the production lines within ADM as part of ongoing process improvement and Lean efforts. Completed Eight (8) week Six Sigma Black Belt training at Johnson and Johnson’s Cordis facility in Miami Florida as sole representative of Lake Region Medical.

Started Laser Solutions, Inc. with proprietary Automated Laser Marking system that Laser Marked 2D Datamatrix codes into circuit boards.  Sold Automation Laser Marking Systems to Motorola, TWR, Delphi Automotive, Jabil Circuits and Zenith Corporation. Co Marketed with Symbol Technologies and Polaroid Corporations. Introduced technology to the Automotive Industry Action Group (AIAG) at world Headquarters in Detroit MI. Within 2 two years Datamatrix coding of PCB’s was made a standard by AIAG. First to develop the implementation of laser marked 2D codes into PCB's in the late 90's.  Management of 7 employee engineering company. Company went from less than $200,000 total sales in 1998 to over $2,000,000 in 2004. Company was sold in 2005