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Sr. Packaging Process Engineer

Smith+Nephew

Memphis, TNOnsitePosted 20 days ago
Full TimeSenior LevelManufacturing & CMCMedical Device
Original posting ↗

Summary

Be part of a successful Packaging Process Engineering team driving innovation in packaging processes and equipment for orthopedic medical devices. Located in Memphis, you'll make a meaningful impact by supporting new product launches and leading cost-improvement efforts in a collaborative, team-focused environment.

Job description

What will you be doing?

  • 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.

What will you need to be successful?

  • 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 but not required.
  • Experience with ISO 11607, FDA, GMP, ASTM and ISTA standards.
  • Effective communication and technical writing skills.

Requirements

  • Bachelor's degree in Packaging Engineering, Mechanical Engineering, Industrial Engineering, or related technical area
  • Minimum 5 years of packaging experience in regulated industry
  • Experience with ISO 11607, FDA, GMP, ASTM and ISTA standards
  • Effective communication and technical writing skills

Benefits

  • 401(k) Matching
  • 401(k) Plus
  • Discounted Stock Options
  • Tuition Reimbursement
  • Flexible Time Off
  • Paid Holidays
  • Flex Holidays
  • Paid Community Service Day
  • Medical, Dental & Vision
  • Health Savings Account
  • Employee Assistance Program
  • Parental Leave
  • Fertility & Adoption Assistance
  • Fitness Club Discounts
  • Travel Discounts

Company overview

Smith+Nephew is a global portfolio medical technology company with a rich history dating back to 1856, originally founded as a chemist shop in Hull, UK. The company specializes in the repair, regeneration, and replacement of soft and hard tissue through innovative medical devices and technologies. Operating through three core business units—Orthopaedics, Sports Medicine & ENT, and Advanced Wound Management—Smith+Nephew serves healthcare professionals and patients in over 100 countries worldwide. With approximately 18,000 employees, the company generated annual sales of $5.5 billion in 2023 and is listed on both the London Stock Exchange (FTSE100) and New York Stock Exchange. Their product portfolio includes joint replacement systems, robotics-assisted surgical platforms, sports medicine implants, advanced wound care solutions, and ENT technologies. The company is pioneering new frontiers in medical technology, including Spatial Surgery systems that integrate augmented reality and real-time data processing for enhanced surgical precision. Smith+Nephew's mission centers on their "Life Unlimited" purpose, aiming to restore patients' bodies and self-belief through technological innovation that removes limitations on living.

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