Sr. Packaging Process Engineer

• 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.

• 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.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.    

• Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement  
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day  
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program 
• Training: Hands-On, Team-Customized, Mentorship  
• Extra Perks: Discounts on fitness clubs, travel and more!  

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Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.