Innovative and driven Senior Level Engineer with experience in leading cross-functional teams for design and manufacturing of components, products, and equipment. Successful record of improving processes, increasing quality and reducing cost.
- Innovative/creative component and system design – concept to completion using SolidWorks
- Expert troubleshooter and rapid problem solving – keeping projects on track and eliminates reoccurrence
- Excellent communication skills – to interact with customers, interdepartmental associates, and suppliers
- Pharmaceutical and medical device knowledge – FDA, GMP, ISO, CE
Confidential, Charlottesville, VA 2005 - 2011
Principal Mechanical Engineer
- Led cross-functional team to develop innovative new laser head for in-line inspection system that is 50% smaller, weighs 75% less, 20% more flexibility with no cost increase to the laser head it replaced.
- Developed a heated bench top laser system for measuring the moisture content within tablets in sealed vials.
- Designed a bench top laser system to measure the oxygen content in the headspace of food product containers that resulted in a significant cost savings for the customer.
- Designed a table top laser system to measure the oxygen content within flexible nutrient bags.
- Project manager for in-line laser Spectroscopy Systems for liquid and lyophilized parental drugs.
- Managed the design, development and manufacture of a complete visual inspection line for a lyophilized drug, which included four manual inspection booths, two bi-flow tables, a laser spectroscopy system, an ink jet printer, and camera inspection of applied serial code.
- Maintain existing mechanical designs for all instruments and related equipment using SolidWorks.
- Maintain engineering database, documents and change control system.
Confidential, Franklin Lakes, NJ 2005 – 2005
Senior Engineer (5 month contract position)
- Led a cross-functional team in redesigning a single-use-disposable-syringe for use by the World Health Organization to meet revised specifications.
- Coordinated with the manufacturing division of Becton, Becton’s in-house lab and the World Health Organization’s independent testing facility to ensure that all testing protocols and equipment used were identical.
Confidential, Meriden, CT 2002 - 2004
Manager, Special Projects
- Designed a filter capsule for removing “Lipids” from blood for use in-line with patients.
- Developed a new process and material for making “depth” type filters, patent 7,645,312 issued 2010
- Responsible for the development of new disposable flexible filtration systems for the healthcare market.
- Conducted research and development of new cellulose filter materials for the pharmaceutical market.
- Resolved filter design and manufacturing issues to improve quality.
Confidential, Charlottesville, VA 2001 - 2002
Owner and President
- Consulted on mechanical design and analysis for many industries, including Biotech and Pharmaceutical.
- Designed a 12-parallel column chromatography system using disposable plastic columns.
- Designed a heating/cooling chamber for glass vials for headspace gas analysis using diode laser technology.
- Designed an automated unloading system to transfer vials from their delivery box into a steam processing system.
- Created a conceptual layout of a vacuum chamber with several different detection options for a high power E-beam facility being developed by a consortium of Universities.
Vice President, Product Engineering & Support
Vice President, Engineering
Director, Product Development
- Directed the design and development of parallel path automated chromatography systems using low-pressure disposable plastic columns and high-pressure stainless steel columns.
- Managed staff of 18, responsibilities included custom software, engineering procedures, documentation, and the generation of operators, service and OEM manuals.
- Developed new products that fueled Biotage’s rapid growth from $2.5 million to $18 million in sales.
- Created the engineering procedures and standards, specified the documentation methods and the testing procedures for all standard and custom systems, including the selection and installation of a PDM system
- Led the engineering effort for ISO 9002 certification.
- Led Kaizen events that Biotage held to improve product flow and quality.
- Implemented Solidworks Solid Modeling for the development of all new products.
Confidential, Fairfield, NJ 1988 – 1993
Manager, Design Engineering
- Designed vortex flow filtration systems employing Taylor vortices to improve performance. Additional responsibilities included engineering procedures, drafting standards, design, and development of production equipment.
- Created working prototype of the “MARCO” rotating disc filtration system.
- Developed the “ESP” series of Ultra-filtration systems with an automated self-cleaning cycle.
- Designed the “PACESETTER” vortex flow filtration system.
- Created and implemented engineering procedures and standards.
- Reduced costs of the “BENCHMARK” filtration system by 65% in six months.
Confidential, Glen Cove, NY 1983 - 1988
Chief Mechanical Engineer
- Supervised nine engineers in the design and development of production and test equipment used to manufacture filter media. Responsible for the operation of the prototype machine shop/laboratory, which employed a manager, twelve machinists, and four technicians.
- Devised a method to measure the deflection characteristics for a single pleat of a pleated filter.
- Wrote corporate engineering procedures and drafting standards manual and organized engineer training.
- Designed and built a high-speed X-Y table and transfer mechanism to cut and place filter discs into housings.
- Designed the production equipment for the “PROFILE” melt blown filter.
Confidential, Blacksburg, VA
Instructor, Mechanical Engineering 1979 - 1983
- Instructed the following undergraduate courses:
- Kinematics and Dynamics of Machinery Machine Design
- Mechanical Vibrations Mechanical System Analysis
- Instrumentation Laboratory
Confidential, Bracknell, UK and Charlottesville, VA 1977-1979
- Conducted shock analysis for the fin stabilizer system of military ships using the FEA program NASTRAN.
- Performed stress analysis to measure the deflection of stabilizing fins under loads up to 100 tons.
- Wrote interactive programs to perform both static and dynamic analysis of beams and shafts.
- Investigated the premature failure of a fin stabilizer and recommended design changes to prevent future failures.
EDUCATION & PROFESSIONAL
Ph.D. Mechanical Engineering
M.Phil. Production Technology
M.Sc. Mechanics of Solids
B.Sc. Mechanical Engineering
Member American Society of Mechanical Engineers Since 1983
Bioprocessing Equipment Main Committee 1990 - 1995
Bioprocessing Executive Committee 1990 - 1995
Bioprocess Subcommittee on Seals 1991 - 1995 Winter Annual Meeting Session Co-Chair 1991
Dobie, M. J., Leavesley, P. J., and Knight, C. E., “Residual Strain and Strength Loss in Filament Wound Circular Rings”, Union Carbide Research Contract Y01 for Oak Ridge National Laboratory, Sept. 1981.
Leavesley, P. J., and Knight, C. E., “An Analytical Model of Strength Loss In Filament Wound Spherical Vessels”, ASME Journal of Pressure Vessel Technology, Vol. 109, No. 3, Aug. 1987, pp352-356.
Rolchigo, P. M., Leavesley, P. J., and Yavorsky, D. P., “High Performance Vortex Flow Filtration”, Bioprocess Engineering Symposium, 1990.
7,645,312 Pleated multi-layer filter media and cartridge
6,802,968 Chromatography apparatus
6,436,284 Chromatography apparatus
6,171,486 Liquid chromatography column
6,132,605 Apparatus and method for making a sealable connection to a chromatography cartridge
6,090,278 Apparatus and method for sealing a plurality of chromatography columns
6,019,897 System for simultaneously pumping solvent for a plurality of chromatography columns
6,001,253 Liquid chromatography column
5,601,708 Apparatus for pressurizing a removable chromatography column