Concepts To Reality provides a one stop solution for a full range of services to make your concepts a reality....Featuring Advantaflex BioPharmaceutical Grade Tubing and overmolds, Integrating customized, Manifold assemblies, tubing sets, container closures, bioprocessing components, packaging and sterilization management services providing you with the advantages of single-use technologies to benefit your bioprocess applications

Consulting Biopharmaceutical Single-use products; Product Design for single use bioprocess fluid transfer systems used for pharmaceutical manufacturing.

I am an Engineering professional with extensive experience in the Medical Device and Bioprocessing industry. I have 20 + years of experience I have a proven track record for managing Plant Operations, Product development, and demonstrated excellent competency in team building. Experienced with establishing Quality Systems, facilitating change management, corrective actions (CAPA), maintaining customer relationships while providing conflict resolutions. I have a very strong work ethic, and the ability to positively motivate teams toward objectives.

Single-Use Bioprocessing Fluid Transfer Products. Built annuals sales from start-up at 120K/yr to 6M at point of acquisition. Manage new product proposals and design team for technology transfers to manufacturing.Develop standard product catalog for web-based presence. Develop sales goals objective for sales representatives.Provided technology solutions for customer based applications.Develop new product accounts for major biopharmaceutical manufacturers such as Genetech, Amgen, and Pfizer. Patent Pending: Overmolding process for tubing interconnects

Single-Use Bioprocessing Fluid Transfer Products. Develop Quality System Requirements.Support integration of Great Plans enterprise software to support order entry processing. Integrate Class 10, and Class 100,000 clean roomsDirect/Develop team for over-molding capability and techniques for single-use products.Manage product floor process flows and efficiencies. Manage production schedules and inventory control.Patent Applications for injection molding process.

Powered Surgical/Arthroscopic InstrumentsSupport to the production floor, Design team, product transfers. Manage the design and development of new equipment; tooling and fixtures used in the manufacture and inspection of medical devices. Returned Goods Customer Service Technical Engineer supporting repair technicians. Supported implementation of World Class Manufacturing Principles (6 Sigma & Kaizen Methods).Team leader in the transfer of acquired company processes into existing plant layout (30,000 sq.ft.) and integration of process flows.Interface with customers to resolve operating room technical issues.Developed automated - computer controlled dynometer test system for pneumatic motors.

Communications Equipment Determine and document root cause failure(s) on electromechanical, electronic components and materials utilized in military communications equipment. Utilize analytical equipment such as scanning electron microscope, X-Ray spectroscopic analysis, micro-sectioning and metallurgical analysis. Formal Reporting to the D.O.D. regarding conclusions and corrective actions.Part of the start-up team to establish a Failure Analysis Laboratory to support Reliability Engineering.Established Scanning Electron Microscope maintenance procedures and schedules.

Weapon Systems, Radar SystemsDetermine and document root cause failure(s) on electromechanical, electronic components and materials utilized in the manufacture of avionic weapons systems. Utilize analytical equipment such as scanning electron microscope, X-Ray spectroscopic analysis, micro-sectioning and metallurgical analysis. Formal Reporting to D.O.D.Identified critical cause for test flight failure on Paveway II laser guided bomb.Identified the root cause for high rejection rates regarding solderability of PCB used in Harpoon guidance systems.Established a computer controlled electronic component testing to screen electronic performance prior to physical examination.