Process Engineer III (Kennesaw, GA)

Company Overview:

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion's four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com.

Position Overview:

The Process Engineer III is responsible for providing process engineering support for all product manufacturing departments. Supports manufacturing operations to ensure consistent adherence to the standard operating procedures and business continuity. Initiates process improvement initiatives to improve the efficiency of current manufacturing processes, as well as develop new processes to improve manufacturing efficiency. Supports new product launches by collaborating with other functional areas and providing process engineering expertise during the implementation of processes or equipment.

Responsibilities:

• Coordinate and manage multiple, often concurrent, Engineering Changes for critical process and design changes throughout the product life cycle.
• Works closely with Operations, Quality Engineering, R&D, Quality Assurance, and Regulatory to conceptualize, develop, and implement engineering changes for raw materials, tooling, manufacturing processes and equipment.
• Lead business continuity and second-source changes to prevent line down situations by identifying, sourcing, qualifying, and implementing alternative materials or procedures.
• Author and execute technical studies. Collect, statistically analyze, and develop report packages to support validations and engineering studies
• Serve as SME for commercial products, and respective manufacturing processes. Assess impacts of changes on DV&V testing (shelf life and distribution).
• Lead shelf life and simulated distribution studies for commercial products, and ensure studies comply to Artivion policies and effective standards.
• Serve as SME for equipment, responsible for User Requirement Specification, equipment start-up, debug, and qualification (IQ/OQ) of manufacturing and facility equipment. Troubleshoot existing equipment and processes. Identify and coordinate implementation of repairs.
• Identify, develop, and implement new or improved manufacturing processes and equipment. Design and execute test plans to identify critical factors (i.e. DOE, MSA), assess upstream and downstream impacts of changes, and expand process knowledge. Determine budget requirements and ROI.
• Develop and implement test methods for raw materials and commercial products. Ensure test methods comply to Artivion policies and industry standards.
• Maintain and expand in-depth knowledge of pertinent Manufacturing Technologies, and industry standards, and disseminate this information as requested to engineering and operations groups.
• Revise drawings of intermediate and final products, manufacturing tools, and other drawings using CAD software.
• Maintain Device Master Records for commercial products.
• Assist in audit deliverables and/or CAPA investigations and deliverables as assigned by management

Qualifications

• Bachelor's degree in Engineering (Mechanical, Chemical, Biomedical or related field of engineering).
• Typically requires 4-6 years of medical device, tissue product or related engineering experience (2-4 years with Masters in Engineering).
• Familiarity with Computer Aided Design (CAD) preferred
• Experience with MiniTab statistical software
• Green Belt in 5S/Lean Manufacturing preferred
• Experience with tissue processing and/or chemical processing preferred
• Comfortable commuting to Kennesaw location 4 days per week.