Operations Management Consultant: Vendor Qualification, Precision Manufacturing and Medical Device Fabrication (1234)
Expertise
Design and Development:
Transverse connector for interlaminal spinal fixation system.
Inter-vertebral spinal fixation body and screws.
Tubing for cardiac and endoscopic applications.
Dental implants (abutment, coping, drills, adapters).
Infusion pump motor subassembly.
Sliding mechanism and support structure for IT and Industrial application.
Vendor Qualification and Development:
Fabrication and machining of bio-mechanical parts and devices.
Post fabrication and assembly processing including surface finishing, coating, laser welding, and electromechanical assembly.
Metal, plastic, electrical components and subassemblies.
Cleaning, sterilizing, packaging medical components.
Metal hardening, burring, and heat treatment.
Mechanical, electrical, and biological testing.
Manufacturing and test equipment, calibration.
Raw material (metal, plastics, chemicals, packaging components) specifications and recommendations.
Manufacturing Processes:
Precision manufacturing CNC, Swiss lathe, milling and grinding.
Metal fabrication, injection molding, welding, surface finishing, coating, bio cleansing, sterilization and packaging.
Electromechanical assembling techniques.
Medical device testing and labeling.
Regulatory and Quality Systems: Design and developed under following medical device standard:
ISO 9000 / ISO 13485 / ISO 14644.
21 CFR Part 820 - QSR, cGMP.
PMA, 510(k) Class I and II.
QS 9000, ISO 14971 Risk Analysis.
Materials:
SS, Ti and other implant grade alloys.
Hypo, Endo and Stent material.
Medical grade plastics and specialty alloys.
Project Management:
Medical Implant design to launch.
Electromechanical subassemblies for auto seats.
Medical diagnostic devices for scanning and imaging devices.
Operations Management:
Purchasing and vendor management.
Production, inventory, materials.
Process and manufacturing engineering.
Compliance, validation, and maintenance.
Tooling (design, development and modification.
Resources and strategic planning.
Budgeting, equipment selection.
Safety, work place regulation, employee development.
Design and Material Review Board.
Experience
Independent Consultant 2004 - Present
Microcision, LLC, VP of Operations and Engineering 1999 - 2003
Designed, developed and project managed orthopedic medical devices, electromechanical devices, other implants and surgical instruments from market evaluation, design controls, development, and approval, production to market release.
Project managed development of transverse connectors and thoracolumbar fixation system from concept to commercialization; setup and maintained device master record and design history files.
Developed and integrate technologies into next generation implant platforms.
Approved, developed and audited key suppliers and integrated other resources.
Developed and executed validation protocols for design, processes, equipment and facility. Implemented ISO13485, QSR and cGMPs and institutionalized SOPs.
Johnson Controls, Inc., Supply Chain Materials Manager 1998-1999
Supply chain and materials management of JIT auto seats and interior parts for GM.
Jonathan Manufacturing Co., Materials Manager 1994-1997
Supervised production control, materials planning and procurement activities.
Coordinated inventory planning and distribution in short lead time complex metal fabrication of steel and aluminum slide mechanism and support structures.
Involved in staff development, process improvement, ISO 9000 compliance, delivered variety of training programs.
Set-up Maquiladora program, negotiated and established procedures with US & Mexican Customs, brokers, transit carriers, Mexican Industrial and HR agencies.
Participated in setting up Mexicali plant including equipment installation, staff hiring and operation set-up.
Vogel Petterson Furniture Co., Production and Inventory Manager 1990-1994
Supervised production scheduling, inventory management, distribution logistics, and forecasting.
Involved in product development and standardization, product obsolescence, cost reduction and facility improvement.
Education
M.S., Operations and Engineering Management, New Jersey Institute of Technology
B.S., Mechanical Engineering, NED University of Engineering & Technology, Karachi