Sr Manufacturing Engineer I&R

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.

As part of the Continuous Improvement Team, provide Engineering Support and Guidence for the Imaging & Resection product line. Design, develop, implement and improve manufacturing processes to produce cost effective quality medical device products and systems. Provide manufacturing engineering expertise to create, document and implement required procedures and documents.

* Work with project teams to identify issues and risks. During new product development integrate with Engineers, Design Engineers, Quality Engineers and the Packaging Department/and or Production Department to ensure cost effective new product development and introduction into manufacturing. * Develop a continuous improvement culture, skills sets and tools to enhance quality and operational excellence. * Lead/support process improvement initiative. * Introduce new equipment, products, and processes. Utilizing industry standard project management tools and techniques. * Present process and equipment recommendations to Leadership Team with regular and timely reviews that will define team roles, responsibilities, and accountability to project plans for implementation. * Initiate new projects and be the Project Leader for key improvement initiatives, identifying best practices. * Develop an understanding of the current manufacturing processes and identify targets for improvement in transactional and operational efficiencies. * Develop manufacturing Work Instructions. * Provide process support on manufacturing technical issues. * Provide process and equipment expertise and support for daily clean-room sterile packaging efforts/and or production efforts. * 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. * Lead and/or assist with implementation of packaging design/and or production specifications into manufacturing. * Monitor timelines and project deliverables to ensure adherence with approved project plans for manufacturing process development. * Develop protocols and coordinate validation of equipment and processes. * Stay current with methods used in the medical device industry to advance technologies. * Participate in defining Preventive Maintenance programs for clean room equipment/ and or production equipment associated with packaging or production activities. * Investigates and test in time reliability and quality improvements * Designs tooling and fixturing to support process 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. * Confers with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards. * Estimates production times, staffing requirements, and related costs to provide information for management decisions. * Applies statistical methods to estimate future manufacturing requirements and potential. * Provide process and equipment expertise and support. * 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. * 7+ years of manufacturing process improvement experience required. * Proven experience in leading process improvement projects. * Experience in closure of MRB’s through root cause analysis and six sigma methodologies * 5 year’s experience in ram E.D.M. technologies * 3 year’s experience in development of 3 dimensional electrodes from solid model geometry * Centerless grinding experience prefered * Laser welding experience prefered * Medical device manufacturing environment preferred. * Experience in work flow optimization, work measurement, efficiencies. * Recognized process improvement training (Lean, Six Sigma) preferred. * Knowledge and Skill Requirements/Specialized Courses and/or Training: * Ability to work independently and effectively with cross functional teams. * 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 / CAM. * Experience with planning and conducting “Design of Experiments” to validate equipment and processes. * Experience in completing technical documentation for engineering and manufacturing. * Familiarity with clean room practices preferred. * Project management skills. * Solidworks experience preferred * Gibb’s C.A.M. experience preferred * Metal cutting equipment, molding, EDM, grinding equipment, finishing equipment, printing equipment, sealing equipment and custom fixturing.