Sr Manufacturing Engineer - Chem Cleaning

Welcome to Arthrex we are a global medical device company and leader in new product development and medical education in orthopaedics. With a corporate mission of helping surgeons treat their patients better, Arthrex has pioneered the field of arthroscopy and developed more than 7,500 innovative products and surgical procedures to advance minimally invasive orthopaedics worldwide.

Provide daily hands-on interaction with the manufacturing teams in support of cleaning processes and equipment. Provide detailed engineering analysis and documentation in the management of material disposition, manufacturing process updates, qualification activities, and CAPA's. Work with the calibration and maintenance groups to ensure that equipment maintenance and calibration is completed on time.

* Partner with the Development organization to develop capable, cost effective cleaning processes and methods for new product related materials and components. * Work with project teams to proactively identify issues and risks. * Identify evaluate, and implement continuous improvement opportunities in order to optimize product design, process performance, and manufacturing methods. * Perform and or support, Equipment Installation, Process Characterization, Operational Qualification, and Performance Qualification (IQ/OQ/PQ) activities, as well as Software Validation and Test Method Validation for cleaning equipment and cleaning processes. * Generate all related documentation in compliance with internal and external requirements. * Develop technical solutions to difficult problems, finding solutions that are thorough, practical, and consistent with organization objectives. * Coordinate with the operations and planning to prioritize and expedite the flow of parts through the parts cleaning and passivation areas. * Prepare specifications and develop quotations for all new and upgraded cleaning and passivation process equipment. * Responsible for the coordination and management of both internal and external F.A.T., S.A.T., F.A.I., and validations. * Support industrial engineers in generation of area metrics, cost evaluation, and OEE data. * Monitor and routinely update Mangers, supervisors, and Project Engineers on the progress of equipment being built at external suppliers. * Provide technical support to production and engineering personnel. * Perform duties in compliance with Standard Operating Procedures and to company Quality Management requirements. * Provide on time project updates, peer/self-assessment, and successful completion of all core and functional training requirements. * Work in concert with EH&S to develop necessary safety procedures. * Work in conjunction with SSBS to understand and develop the standards and evaluation of process water. * Lead/support process improvement initiative. * Introduce new equipment, products, and processes. Utilizing industry standard project management tools and techniques. * Develop an understanding of the current manufacturing processes and identify targets for improvement in transactional and operational efficiencies. * Develop manufacturing Work Instructions. * Develop action plans to achieve short and long-range efficiency goals, selection of new production methods, designs of production fixtures, and methods to monitor efficiencies. * Stay current with methods used in the medical device industry to advance technologies. * Participate in defining Preventive Maintenance programs for production equipment associated with production activities. * Investigates and test in time reliability and quality improvements * Drives automation to replace the manual process as much as possible * Ensure Information and documentation is consistently accurate * Analyzes and plans workforce utilization, space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency. * Estimates production times, staffing requirements, and related costs to provide information for management decisions. * Applies statistical methods to estimate future manufacturing requirements and potential. * Identify issues and risks to ensure cost effective new product development and introduction into manufacturing. * May supervisor other Engineering, Prototype or Programming personnel.

* Bachelor’s degree in Engineering, Science or Mathematics. BS in Chemical Engineering preferred * 4+ years of engineering experience in the medical device parts clean and passivation processes required. * Minimum 7 years total manufacturing & process improvement experience required. * Proven experience in leading process improvement projects. * Medical device manufacturing environment preferred. * Experience in work flow optimization, work measurement, efficiencies. * Recognized process improvement training (Lean, Six Sigma) preferred. * Ability to work independently and effectively with cross functional teams. * Knowledge of manufacturing process qualification (IQ/OQ/PQ), Software Validation, and Test Method Validation. * Thorough understanding of manufacturing processes. * Detail oriented with strong analytical skills. * SPC (Statistical Process Control) knowledge. * Strong communication skills and ability to communicate effectively with technical and non-technical staff. * Experienced user of MS Office Suite and CAD. * Experience with planning and conducting tests to validate equipment and processes. * Experience in completing technical documentation for engineering and manufacturing. * Familiarity with clean room practices preferred. * Project management skills preferred. * Solidworks experience preferred * Metal cutting equipment, molding, EDM, grinding equipment, finishing equipment, printing equipment, sealing equipment and custom fixturing.