Packaging Engineer - Medical Devices & ISO 11607 Expert

ATR International; Memphis (TN); On-site; USD 85,000 - 110,000; Full time

Job summary

ATR International is seeking a Packaging Development Specialist to own end-to-end packaging for terminally sterilized medical devices. You will drive design inputs/outputs, validation activities, and risk assessment while aligning with ISO 11607 and ISTA standards.

You will design packaging exteriors, manage documentation, and support GMP compliance in manufacturing facilities, ensuring state-of-the-art file updates and regulatory alignment.

Qualifications

• Experience designing packaging for terminally sterilized medical devices.
• Experience validating packaging processes per ISO 11607-2.
• Experience with sterilization methods (ETO, radiation).
• Experience implementing risk mitigation per FDA/ISO standards.
• Documentation management and GMP coordination experience.

Responsibilities

• Self-manage packaging development activities including design inputs/outputs and risk assessments.
• Design, develop, and test packaging protocols/reports for devices.
• Ensure EU MDR guidelines are met and update files to state-of-the-art expectations.
• Provide manufacturing support and participate in GMP documentation.

Skills

Packaging system design

ISO 11607 compliance

FDA QS Regulation

Sterilization knowledge

Risk management

Six Sigma/DFSS

CAD tools CREO/SolidWorks

Statistical analysis Minitab

Education

Bachelor of Science in Packaging, or Mechanical/Biomedical Engineering

Tools

CREO

SolidWorks

TOPS

Minitab

Job description

ATR International is seeking a Packaging Development Specialist to own end-to-end packaging for terminally sterilized medical devices. You will drive design inputs/outputs, validation activities, and risk assessment while aligning with ISO 11607 and ISTA standards.

You will design packaging exteriors, manage documentation, and support GMP compliance in manufacturing facilities, ensuring state-of-the-art file updates and regulatory alignment.