Senior Packaging Process Engineer — Medical Devices Innovator

Smith Nephew; Memphis (TN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

401k Matching Program

Discounted Stock Options

Tuition Reimbursement

Flexible Time Off

Paid Holidays

Parental Leave

Medical/Dental/Vision

Employee Assistance Program

HSA Employer Contribution

Mentorship

Fitness Discounts

Job summary

Smith Nephew in Memphis is seeking a Packaging Process Engineer to lead packaging projects from concept to implementation. You will pilot new technologies, develop processes for sealing, filling, labeling, and vision systems, and support launches with regulatory SME input.

The role emphasizes cross-functional collaboration, GxP awareness, and strong documentation practices to ensure compliant packaging for sterile and non-sterile products.

Qualifications

• Bachelor's degree in Packaging Engineering, Mechanical, Industrial Engineering, or related technical area.
• Master's degree preferred.
• Minimum 5 years of packaging experience in regulated industry.
• Experience with heat-sealing, form-fill-seal automation, modified atmosphere packaging, PLC/HMI, labeling, and vision systems.
• Experience with ISO 11607, FDA, GMP, ASTM and ISTA standards.
• Effective communication and technical writing skills.

Responsibilities

• Lead packaging process engineering projects from concept through implementation.
• Identify and pilot innovative technologies and equipment to improve packaging processes.
• Develop packaging processes, including sealing/forming equipment, vision systems, labeling/barcoding, eDHR, and in-process quality testing.
• Support new product development and design transfer activities to ensure launch readiness.
• Provide SME support for regulatory submissions and reviews.
• Mentor packaging engineering and production staff.
• Establish and maintain packaging validation processes in ISO 11607-2 compliance.
• Provide technical support to local and remote packaging operations for validations, documentation, and problem solving.
• Investigate packaging and labeling concerns to ensure compliance with sterile and non-sterile standards.
• Participate in NC/CAPA processes and complaint investigations.
• Support packaging equipment, product, and supplier transfers, as well as design changes.
• Create and maintain process documentation within change management systems.

Skills

Communication

Technical writing

Team collaboration

Education

Bachelor's degree in Packaging Engineering, Mechanical Engineering, Industrial Engineering, or related technical area

Master's degree preferred

Job description

Smith Nephew in Memphis is seeking a Packaging Process Engineer to lead packaging projects from concept to implementation. You will pilot new technologies, develop processes for sealing, filling, labeling, and vision systems, and support launches with regulatory SME input.

The role emphasizes cross-functional collaboration, GxP awareness, and strong documentation practices to ensure compliant packaging for sterile and non-sterile products.