Sr. Packaging Process Engineer

Smith+Nephew•Memphis, TN

4d•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 innovation in packaging processes and equipment for orthopedic medical devices, with a focus on new product launches and cost-improvement efforts. The engineer leads projects from concept through implementation, supports product development and design transfer, and provides technical support to packaging operations. The position also contributes expertise to regulatory submissions, packaging validations, investigations, and process documentation.

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.
Medical device or health care product industry experience preferred.
Experience with form-fill-seal automation, modified-atmosphere packaging, PLC/HMI programming, labeling processes, and vision systems preferred.

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-expert support 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 align with current standards for sterile and non-sterile medical devices.
Participate in nonconformance/CAPA processes 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.