Packaging Engineer II - Exempt

Join our team in Memphis, TN, where you will have the opportunity to work in a dynamic environment focused on the design and development of packaging systems for terminally sterilized medical devices. As a Packaging Engineer, you will play a crucial role in ensuring the safety and efficacy of our products.

Must Have:

• Design and development of packaging systems for terminally sterilized medical devices as per ISO 11607-1 and corresponding ASTM and ISTA standards.
• Validation of processes for packaging medical devices as per ISO 11607-2, including forming, sealing, and assembly of sterile barrier systems.
• Strong working knowledge of FDA Medical Devices Part 820 Quality System Regulation and Medical Device Good Manufacturing Practices.
• Experience with medical device sterilization methods (e.g., ethylene oxide, radiation).
• Experience implementing risk mitigation actions with knowledge of packaging or process and Risk Management as per FDA & ISO standards.
• Six Sigma/Design for Six Sigma experience, and/or knowledge of Process Excellence tools.
• Working knowledge of SolidWorks or other packaging CAD programs (e.g., TOPS, SolidWorks, CREO).
• Experience with Minitab or other statistical software.

Nice to Have:

• Experience developing Medical Device Case and Trays used with Steam Sterilization.

Responsibilities:

• Self-management of Packaging Development activities including design and quality deliverables involving strategy, requirements flow down, reviews, roadmap alignment, design inputs, design outputs, design characterization, usability, risk management, manufacturing support, design validation, labeling, change management, and support issues.
• Design, develop, and create test protocols/reports for a wide variety of containers used for the protection, display, and handling of products.
• Determine packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required.
• Design package exteriors considering factors such as product identification, operating room workflow, aesthetic quality, printing, and production techniques.
• Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants.

Top 3 Technical Skills Required:

• Medical Device Packaging Design (Sterile Packaging / Steam Sterilization Cases).
• Project Management skills, including timeline management and design history file ownership.
• Fully capable and comfortable with CREO drawing software.

Education Required:

Bachelor of Science in Packaging, Mechanical Engineering, or Biomedical Engineering.

Years’ Experience Required:

Internship (2 to 7 years of experience preferred).

Responsible for ensuring EU MDR Guidelines are met, and suggest where remediation steps may be needed. Update existing files to meet state-of-the-art file expectations.

This position requires working onsite in Memphis, TN, 4 days a week, with a 40-hour work week.

Additional Information:

Interviews are scheduled to take place between September 15 to October 9. The role will support Spinal and Biologics products.