Sr. Packaging Process Engineer

Smith & Nephew•Memphis, TN

2d•Onsite

About The Position

Smith+Nephew is seeking a Senior Packaging Process Engineer to join its Packaging Process Engineering team in Memphis. The role supports packaging process and equipment innovation for orthopedic medical devices, new product launches, and cost-improvement initiatives. The engineer leads projects from concept through implementation, supports product development and design transfers, and provides technical assistance to packaging operations. The position also establishes packaging validation processes and helps ensure packaging systems meet applicable standards for sterile and non-sterile medical devices.

Requirements

Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Industrial Engineering, or a related technical area.
At least 5 years of packaging experience in a regulated industry.
Experience with heat-sealing processes and equipment for trays and pouches.
Experience with ISO 11607, FDA, GMP, ASTM, and ISTA standards.
Effective communication and technical writing skills.

Nice To Haves

Master’s degree preferred.
Experience in the medical device or health care product industry preferred, but not required.
Experience with form-fill-seal automation, modified atmosphere packaging, PLC/HMI programming, labeling processes, and vision systems preferred, but not required.

Responsibilities

Lead packaging process engineering projects from concept through implementation.
Identify and pilot innovative technologies and equipment to improve packaging processes.
Develop packaging processes involving sealing and forming equipment, vision systems, labeling and barcoding, electronic data systems (eDHR), and in-process quality testing.
Support new product development and design transfer activities to ensure launch readiness.
Provide subject matter expertise for regulatory submissions and reviews.
Mentor packaging engineering and production staff.
Establish and maintain packaging validation processes in compliance with ISO 11607-2.
Provide technical support to local and remote packaging operations for equipment validations, process documentation, and process problem solving.
Investigate packaging and labeling process concerns and help ensure packaging systems conform to current packaging standards for sterile and non-sterile medical devices.
Participate in nonconformance (NC), corrective and preventive action (CAPA), and complaint investigations.
Support packaging equipment, product, and supplier transfers, as well as design and material changes.
Create and maintain process documentation within change management systems.