Engineer Sr Molding Process

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Requisition : 64042

Location: Ave Maria, FL

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. This best candidate would be responsible for supporting Engineering Manager with all support for the life cycle development of Class I, II and III medical devices, including new product development and maintenance of released products.

This role supports design, development, implementation, and improvement of manufacturing processes to produce cost-effective, quality medical device products and systems. The position provides manufacturing engineering expertise to create, document, and implement required procedures and documents. The role is in Ave Maria, FL and works in the Molding Process Engineering Department. Post-graduate work experience in a manufacturing environment is required.

• 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.
• Support process improvement initiatives.
• 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 define team roles, responsibilities, and accountability to project plans for implementation.
• Initiate new projects and act as Project Leader for key improvement initiatives, identifying best practices.
• Develop an understanding of current manufacturing processes and identify targets for improvement in transactional and operational efficiencies.
• Develop manufacturing Work Instructions.
• Provide process support on manufacturing technical issues.
• Develop action plans to achieve short and long-range efficiency goals, select new production methods, design production fixtures, and monitor efficiencies.
• Lead and/or assist with the 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.
• Investigates and tests reliability and quality improvements; drive automation to replace manual processes where possible.
• Ensure information and documentation are consistently accurate.
• Analyze and plan workforce utilization, space requirements, and workflow; design layout of equipment and workspace for maximum efficiency.
• Confer with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts; evaluate products against specifications and quality standards.
• Estimate production times, staffing requirements, and related costs for management decisions.
• Apply statistical methods to estimate future manufacturing requirements and potential.
• Provide process and equipment support.
• Identify issues and risks to ensure cost-effective new product development and introduction into manufacturing.
• May supervise other Engineering, Prototype or Programming personnel.

• Bachelor’s degree in Engineering.
• 5 years of manufacturing process improvement experience required.
• Experience in leading process improvement projects.
• Medical device manufacturing environment preferred.
• Experience in workflow optimization, work measurement, efficiencies.
• Recognized process improvement training (Lean, Six Sigma) preferred.

• 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…