Sr. Packaging Process Engineer 1

Requisition ID: 58619  Title: Engineer Sr. 1 - Packaging Process  Division: Arthrex Manufacturing Inc (US02)  Location: Pendleton, SC

 

 

 

 

 

 

 

 

 

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 Senior Packaging Process Engineer I for our manufacturing facility in Pendleton, SC. Successful candidates must possess at least 5 years of post education experience. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

Main Objective:

To provide packaging process engineering support to AMI Packaging Operations and INC Packaging Design teams to achieve business goals.  To lead projects involving: rapid commercialization of new products; commercialization of new equipment; improvements to equipment; data collection; process performance improvements; increases in productivity and production capacity; and ongoing reduction of costs. 

 

Essential Duties and Responsibilities:  

• Support new product development/design transfer by leading Packaging Material process development and validation.   
• Develop and support a continuous improvement culture to enhance quality, operational excellence, and cost. 
• Develop and maintain Master Validation Strategies and Master Validation Plans for packaging/sealing/inspection processes. 
• Draft and execute validation protocols and reports (IQ,OQ/PQ) for various packaging and labeling processes including: pouch sealing (impulse, continuous band, vacuum, vacuum+nitrogen flush); blister tray sealing (standard and vacuum+nitrogen flush); label print/apply systems; laser ablation; die cutting; blister thermoforming. 
• Lead the design, development, and commercialization of new equipment including: gathering user requirements, designing equipment mechanical and electrical systems, developing equipment specifications, coordinating quotes and procurement of new equipment with vendors, validation, work instruction development, BOM and Router management, and training of operations. 
• Maintain certification and management of the ISTA-certified Packaging Test Lab.  Coordinate testing assignments to maintain lab Turn-Around-Time goals. 
• Perform and train technicians and engineers on packaging test methods including: distribution testing, accelerated aging, burst testing, peel testing, dye penetration testing, and bubble emission testing. 
• Develop, validate packaging test methods including new test equipment, new tooling/fixturing in response to industry changes or to provide additional capabilities in the test lab or in operations. 
• 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. 
• Design, develop, and manage tooling and fixtures.  Coordinate quotes and procurement of new tooling with vendors.  Assess and execute validation requirements accordingly. 
• Lead the commercialization of new packaging sealing equipment including: developing equipment specifications, coordinating quotes and procurement of new equipment with vendors, validation, and training of operations. 
• Support the maintenance of equipment and tooling once released to production through troubleshooting, repair tracking, and analysis of impact to the validated state. 
• Develop an understanding of current manufacturing processes and identify targets for improvement in data collection/trending, work order transaction processes, and operational efficiencies. 
• Design, develop, and manage packaging/sealing tooling and fixtures and related validation activities.  Coordinate quotes and procurement of new tooling with vendors. 
• Ensure data and documentation are consistently accurate and complete including Work Instructions, Setup Sheets, BOMs and Routers. 
• Applies statistical methods to estimate future manufacturing requirements and potential.  Develop sampling procedures, forms, and instructions for recording, evaluating, and reporting quality and reliability data. 
• Analyzes and plans workforce utilization, space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency utilizing lean techniques when feasible. 
• Estimates production times, staffing requirements, and related costs to provide information for management decisions. 
• May supervise Technician, Engineering, Prototype or Programming personnel. 
• Remain current with ISO/FDA/ASTM/ISTA standards and internal quality assurance policies.  Support Audits as the packaging/sealing subject matter expert. 

 

Education/Experience:<