Manufacturing Engineer II-Sutures

Location: Ave Maria

Requisition

Title:

Manufacturing Engineer II-Sutures

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Manufacturing Engineer II-Sutures. The successful candidate will be responsible for supporting the Engineering Manager with the life-cycle development of Class I, II, and III medical devices, including new product development and maintenance of released products. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

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, skill 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

* 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.

Education and Experience:

* Bachelor's degree in Engineering.

* 2 years of manufacturing process improvement experience required

* Proven 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.

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.

* Strong communication skills and ability to communicate effectively with technical and non-technical staff.

* Experienced user of MS Office Suite and CAD.

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