Senior Packaging Process Engineer I at Arthrex Manufacturing, Inc. in Pendleton, South Carolina

Job Description:

Requisition ID: 55300 Title: Engineer Sr I - 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:

• B.S. in Engineering required; preferably in Packaging Engineering/Packaging Science.


• Minimum of 5 Yrs. experience in Packaging Design and Development or relevant Manufacturing required.


• Proven Experience leading process improvement projects.


• Experience in medical device manufacturing or other health sciences industry preferred.


• Experience working in a Cleanroom environment preferred.


• SAP, miniTab, Solidworks experience preferred.


• Lean Six Sigma Green Belt / Black Belt certification preferred.

Knowledge and Skills:

• Advanced knowledge of Packaging Materials and various Heat Sealing Processes.


• Advanced understanding of supporting manufacturing processes and interdependencies.


• Proficiency in Industry Standards (ASTM, ISTA) Packaging Test Methods.


• Capable of ensuring compliance with ISO 13485, 11607 and FDA 21 CFR Part 820 as related to cGMP and Process Validations.


• Advanced CAD software skills required.


• Proficiency in drafting and executing complex engineering study protocols, DOE's, analyzing data, and writing reports.


• Ability to develop design solutions (small tooling, fixturing) to improve existing test methods or sealing processes.


• Ability to use project management tools (MS Project, Mindview , WorkFront ) to plan projects.


• Ability to prepare a capital equipment budget and justification (ROI).


• Ability to communicate ideas, results, recommendations, and status effectively in oral and written forms.


• Ability to coach & mentor junior level engineers and technicians.


• Ability to create and maintain accurate pFMEAs for assigned processes.


• Ability to apply structured problem solving techniques and develop process design solutions to improve existing manufacturing and/or testing methods.

Medical Device, manufacturing, packaging, engineering, South Carolina, jobs, now hiring

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.