Project Manager and Consultant for Sterile Medical Device Manufacturing, Process Startup, and Quality Improvement

Technical Consultant #1425

Manufacturing process startup, integration, improvement and relocation.
Project management, operations management and quality management with emphasis on medical device manufacturing.
Engineering and product design for manufacturing.
Manufacturing of sterile products on a global basis.
Production process startup, integration, improvement and geographical relocation.
Project management, operations management, and quality management with emphasis on medical device manufacturing.
Manufacturing of sterile products on a global basis.

Company Founder, President 1995 - Present

Founded and managed the start up of a medical device manufacturing company.
For sterile products, established the required manufacturing processes, developed the required Quality Management Systems and certified the operations to ISO 9000 and ISO 13485 standards and obtained CE product approval.

Alcon Laboratories Inc., 1987 - 1995

Director, Technical Services and Projects Surgical Manufacturing

Responsible for ongoing division wide capacity management program through a broad combination of new facilities, plant expansions, OEM and joint venture manufacturing agreements and other appropriate capacity thrusts.
Major accomplishments include authoring the manufacturing management portion of the Alcon Surgical three year Strategic Plan including detailed recommendations for European and Pacific Rim manufacturing initiatives.
Developed the long range facility utilization and expansion plans for the Houston and Sinking Spring facilities.

General Manager, Precision Device Facility

Responsible for the manufacturing, R&D/manufacturing engineering, materials, finance, and support functions of the Alcon Precision Device Facility including day to day management of human resources and quality activities.
Major accomplishments include more than doubling the facility size, increasing employment three fold, and increasing volume twelve fold. Within a five year period the total number of product lines produced increased from two to seven. Facility achieved year to year improvements in quality, cost and customer service via on time delivery.
Additional accomplishments include institution of a plant wide Total Quality Management philosophy and certification to ISO 9001 standards.

Sharpoint Inc., 1976 - 1987

Vice President, Manufacturing

Responsible for management of the manufacturing operations of Sharpoint Inc., a privately owned surgical device manufacturing firm.
Additional duties included product and process development, project management for new construction and facility maintenance activities.

Engineering Manager

Responsible for manufacturing equipment and tooling design and fabrication support to a rapidly growing business.
Supervised design, drafting, and machine shop personnel and facility maintenance activities.
Major accomplishments include managing several relocations of operations to support business growth and the design and fabrication of complex manufacturing equipment.

Rockwell International, 1967 - 1976

Nine years of increasing responsibilities in engineering and production planning functions.