Mark Bohaczyk

Background

About Mark Bohaczyk

Process Development: Equipment Selection, IQ/OQ/PQ, Characterization, Parameters, Process optimization. Design of Experiments, DOE, problem solving, data evaluation and analysis. Process Validation: Create, edit, execute protocols, and write protocol reports. Product Management: Concurrent Engineering, Development, Product Launch, Sustaining Engineering Manufacturing Documentation: BOM, Router, Manufacturing and Inspection/Test Instructions, SOPs Lean Manufacturing: Six Sigma, Kaizen Events, 5S, One Piece Flow, Kanban, JIT, Poka Yoke Project Management: Cost, Schedule, Quote, Customer and Vendor Relations Business Management: Personnel, Budget, Inventory, Production Planning Development and Management of Engineering and Manufacturing Teams Packaging Validation: Parameter Development, Equipment/Material Selection, Sterilization Methods Molding: Injection Molding, Insert Injection Molding, Extrusion, Forming, Mold Tooling, Materials Ultrasonic and Vibration Welding of Plastics, Ultrasonic Cleaning, Plastic Assembly Methods Manufacturing Assembly Jigs, Fixtures and Tooling, Inspection, and Test Fixtures Specialties: Plastics, Injection Molding, Medical Device, Process Development, Validation, Product Launch