Lead Packaging Process Engineer - Medical Devices Innovation

Smith & Nephew; Memphis (TN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

401k Matching

Stock options

Tuition Reimbursement

Healthcare benefits

Paid time off

Job summary

Smith+Nephew in Memphis, TN, seeks a Sr. Packaging Process Engineer to lead packaging projects from concept through implementation. You will drive process improvements for sealing, forming, labeling, and eDHR systems while supporting new product launches and regulatory submissions.

The role requires a bachelor’s in a packaging-related field with 5+ years in regulated packaging, knowledge of ISO 11607/FDA/GMP, and strong communication and writing skills. On-site role with robust benefits.

Qualifications

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Industrial Engineering, or related technical area. Master’s degree preferred.
• Minimum 5 years of packaging experience in regulated industry. Medical device or health care product industry preferred but not required.
• Experience with heat-sealing process and equipment for trays and pouches. Form-fill-seal automation, modified atmosphere packaging, PLC/HMI programming, labeling process, and vision systems preferred by not required.
• Experience with ISO 11607, FDA, GMP, ASTM and ISTA standards.
• Effective communication and technical writing skills.

Responsibilities

• Leads packaging process engineering projects from concept through implementation.
• Identifies and pilots innovative technologies and equipment to improve packaging processes.
• Develops packaging processes, including sealing/forming equipment, vision systems, labeling/barcoding, electronic data systems (eDHR), and in process quality testing.
• Supports new product development and design transfer activities to ensure launch readiness.
• Provides SME support for regulatory submissions and reviews.
• Mentors packaging engineering and production staff.
• Establishes and maintains packaging validation processes in compliance with ISO 11607-2.
• Provides technical support to local and remote packaging operations for equipment validations, process documentation, and process problem solving.
• Investigates packaging and labeling process related concerns, works to ensure packaging systems are consistent with current packaging standards for sterile and non-sterile medical devices.
• Participates in NC/CAPA process and complaint investigations.
• Supports packaging equipment, product, and supplier transfers, as well as design and material changes.
• Creates and maintains process documentation within change management systems.

Skills

Project leadership

Communication

Technical writing

Regulatory knowledge

Education

Bachelor’s degree in Packaging/Mechanical/Industrial Engineering or related

Master’s degree preferred

Tools

Heat-sealing equipment

Form-fill-seal

PLC/HMI programming

Vision systems

Labeling/barcoding

Job description

Smith+Nephew in Memphis, TN, seeks a Sr. Packaging Process Engineer to lead packaging projects from concept through implementation. You will drive process improvements for sealing, forming, labeling, and eDHR systems while supporting new product launches and regulatory submissions.

The role requires a bachelor’s in a packaging-related field with 5+ years in regulated packaging, knowledge of ISO 11607/FDA/GMP, and strong communication and writing skills. On-site role with robust benefits.