Sr. Packaging Process Engineer - ALC

Sr. Packaging Process Engineer – ALC

Division:
Arthrex, Inc. (US01)

Location:

Fort Myers, FL, US, 33912

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 Sr. Packaging Process Engineer – Warehousing & Distribution. This role will provide support in designing and developing packaging solutions that protect products during transportation, storage, and handling. In addition, this position will involve providing cost‑effective solutions for the logistics and warehouse functions in support of Operational and Supply Chain Efficiency goals.

Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

• Designing and developing packaging solutions for the Warehouse Environment:
  • Choose 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.
• Optimization for the Warehouse and Logistics Environment:
  • Determine effective solutions and processes for the Warehouse and Logistics environment to maintain product safety and warehouse and logistics efficiency, considering factors such as weight, volume, stacking strength, pallet configuration, and ease of handling during transportation and storage. Support implementation of new equipment and process projects in the warehouse and new product releases for Private Label and Original Equipment Manufacturers (OEM) products (packaging and labeling).
• Cost improvement initiatives:
  • Identify areas for improvement in warehousing and logistics operations in terms of cost, performance, efficiency, damage reduction, and sustainability.
• Working with various stakeholders:
  • Collaborate with key internal stakeholders (Packaging Engineering, Process Packaging Engineering, Supply Chain, Product Management, etc.) and external stakeholders (packaging material suppliers, transportation providers, etc.) to maximize efficiencies, product protection, minimize damage, and determine optimal solutions for the warehouse and logistics environment.
• Regulations and Standards:
  • Act as SME for regulation and compliance standards for the Warehouse, Storage, and Transport environments, ensuring the warehouse and logistics processes comply with relevant regulations and industry standards (e.g., FDA, EU MDR, ISTA, and other standards).

• Complete understanding and application of principles, concepts, practices, and standards.
• Full knowledge of industry practices and standards.

• Advanced knowledge of Packaging Materials
• Advanced understanding of supporting manufacturing processes and interdependencies.
• Proficiency with 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, Work Front) 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.

• B.S. Engineering required; preferably in Packaging Engineering.
• Minimum of 5 years experience in Packaging Design and Development or relevant manufacturing.
• Proven experience…