Manufacturing Engineer

Manufacturing EngineerDepartment: ManufacturingEmployment Type: Full TimeLocation: Gainesville, FLReporting To: Manager Manufacturing EngineeringDescriptionCreate and maintain the lowest cost, highest quality machining & manufacturing processes, tooling and supporting documentation for all parts produced.Key Responsibilities Create and maintain machining files for all parts produced. Develop tooling and processes for the machining of production items. Implement total machining process and run Verification validation studies. Develop Multiaxis CNC programs from Unigraphics solid models for prototypes and new products as required by approved engineering projects. Troubleshoot machining processes and make CNC program adjustments when necessary. Create machining work instructions. Assist in the development of manufacturing machinists. Train machinists on new product, processes and methods. Identify and execute manufacturing process improvements. To provide shop floor support and interact with other departments such as Quality Assurance and Design Engineering to solve manufacturing problems. Use control processes such as Document Change Notifications to implement process changes. Create and document machining work instructions, operations set up sheets and perform process verifications. Develop schedules to ensure timely completion of projects and provide input in the development of product project schedules. Know and apply the Quality System regulations and any appropriate Federal and International standards. Assist and support other project, tasks, responsibilities, employees, teams, and sales personnel as necessary. Provides project management leadership for the development of new products, & current vendor suppliedproduct or processes into Exactech manufacturing operation.Skills Knowledge and ExpertiseEducation: Bachelor's Degree from an accredited institution or equivalent relevant work experience required.Experience: Three years experience in manufacturing and machining process development. Medical Device Industry a plus. Familiar with GMP's, and Lean Manufacturing.

FDA Part 820 Quality Systems Regulations experience is required preferably in the medical device industry Experience in the development and execution of IQ's/OQ's/PQ documents Strong experience in CNC machining and programming is required. Knowledge of SURFCAM and Unigraphics a plus. Thorough understanding of geometric tolerancing Ability to create programs, G code experience preferred, and design tooling for the manufacture of components from a print or model. Experience writing IQ/OQ/PQ documents. Experience writing Validation verification plans. Experience with medical device materials i.e. titanium, cobalt chrome, stainless steel, UHMWPE