Engineer II - Manufacturing
Arthrex Manufacturing Inc
Sandy Springs, SC
This position will be located at the Arthrex manufacturing facility in Sandy Springs, SC.
The successful candidate for this position must have the ability to travel to the Naples, FL area for initial training as needed by Arthrex.
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.
Essential Duties and Responsibilities:
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. Present process and equipment recommendations to Leadership Team with equipment reviews and 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 operation 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
Drive automation to replace the manual process as much as possible
Ensure Information and documentation is consistently accurate
Analyze and plan workforce utilization, space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency.
Confer with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards.
Estimate production times, staffing requirements, and related costs to provide information for management decisions.