Packaging Engineer II

Memphis, TN (Onsite – 4 days/week)

We’re seeking a Packaging Engineer to support packaging development for medical device products. This role will independently manage packaging projects from design through validation while ensuring compliance with GMP, EU MDR, and medical device requirements.

• Design, develop, and test medical device packaging, including sterile packaging and steam sterilization cases.
• Develop packaging requirements, specifications, design inputs/outputs, test protocols, and reports.
• Support design characterization, validation, risk management, usability, labeling, and change management.
• Manage project timelines and serve as an owner/lead for Design History File (DHF) documentation.
• Review and update existing files to meet current state-of-the-art and EU MDR expectations.
• Provide manufacturing and prototype-line support as needed.
• Ensure packaging protects products from environmental and handling conditions while meeting functional and regulatory requirements.
• Collaborate with cross-functional engineering, quality, manufacturing, and regulatory teams.

• Medical Device Packaging Design – sterile packaging / steam sterilization cases
• Project Management & Documentation – timeline management, DHF ownership, excellent documentation and file organization
• CREO – fully proficient and comfortable creating/reviewing drawings

• Bachelor’s degree in Packaging, Mechanical Engineering, Biomedical Engineering, or related field.
• 3+ years of relevant experience preferred; strong internship/early-career experience may be considered.
• Experience with medical device packaging, GMP, design controls, DHF documentation, and EU MDR strongly preferred.
• Strong organizational, documentation, and communication skills.