Sr. Packaging Process Engineer
About the role
Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. We are actively searching for a Sr. Packaging Process Engineer to support in designing and developing packaging solutions that protect products during transportation, storage, and handling. This role also involves providing cost-effective solutions for the logistics and warehouse functions in support of Operational and Supply Chain Efficiency goals.
Responsibilities
Designing and developing packaging solutions for the Warehouse Environment: Chooses appropriate materials (e.g., cardboard, foams, poly materials, etc.), containers (e.g., boxes, crates, pallets), and other protective packaging materials (e.g., cushioning, strapping, sealing) required to protect the products during storage, transport and handling.
Determines effective solutions and processes for the Warehouse and Logistics environment to maintain product safety and warehouse and logistics efficiency. This includes considering factors like weight, volume, stacking strength, pallet configuration, ease of handling during transportation and storage, etc.
Supports implementation of new equipment and process projects in the warehouse.
Supports new product releases for Private Label and Original Equipment Manufacturers (OEM) product (packaging and labeling).
Identifies areas for improvement in warehousing and logistics operations in terms of cost, performance, efficiency, damage reduction, and sustainability.
Collaborates with Key Stakeholders internal (Packaging Engineering, Process Packaging Engineering, Supply Chain, Product Management, etc.) and external (packaging material suppliers, transportation providers, suppliers, etc.) to maximize efficiencies, product protection, minimize damage, and determining optimal solutions for the warehouse and logistics environment.
Acts as SME for regulation and compliance standards for the Warehouse, Storage, and Transport environments. Ensures the warehouse and logistics processes comply with relevant regulations and industry standards (ex: FDA, EU MDR, ISTA, and other standards).
Requirements
Advanced knowledge of Packaging Materials
Advanced understanding of supporting manufacturing processes and interdependencies
Proficiency in Industry Standards (ASTM, ISTA)
Packaging Test Methods
Knowledge of 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 pFEMAs for assigned processes
Ability to apply structured problem solving techniques and develop process design solutions to improve existing manufacturing and/or testing methods
Gatekeeper for Private Label and OEM products, ensuring that labeling and packaging meet distribution requirements
Qualifications
B.S. Engineering required; preferably in Packaging Engineering
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 warehouse environment required
SAP, miniTab, Solidworks experience preferred
Leverage Lean Six Sigma Green Belt / Black Belt certification preferred
Skills
Advanced knowledge of Packaging Materials
Advanced understanding of supporting manufacturing processes and interdependencies
Proficiency in Industry Standards (ASTM, ISTA)
Packaging Test Methods
Knowledge of ISO 13485, 11607 and FDA 21 CFR Part 820 as related to cGMP and Process Validations
Advanced CAD software skills
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 pFEMAs for assigned processes
Ability to apply structured problem solving techniques and develop process design solutions to improve existing manufacturing and/or testing methods