Packaging Engineer (Medical Devices)

Location: Athens, Texas, United States

Company

hirify.global manufactures specialty medical products for interventional radiology, vascular surgery, interventional cardiology, and oncology.

What you will do

• Lead packaging process and equipment qualifications, including IQ, OQ, and PQ activities.
• Develop, execute, and document validation protocols and reports for packaging processes, equipment, and materials.
• Manage packaging-related CAPAs, nonconformances, investigations, corrective actions, and change controls.
• Provide technical support for manufacturing troubleshooting and packaging-related issues.
• Qualify alternative packaging materials, suppliers, and components, and support new equipment installation and validation.
• Drive continuous improvement while maintaining packaging specifications, validation records, and regulatory documentation.

Requirements

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Materials Engineering, or a related technical discipline.
• 3–5 years of packaging engineering experience in a regulated manufacturing environment; medical-device experience is preferred.
• Experience with process validation, equipment qualification, change control, and CAPA systems.
• Knowledge of packaging equipment, materials, manufacturing processes, and design software such as SolidWorks.
• Familiarity with FDA Quality System Regulation, ISO 13485, and ISO 11607 requirements.
• Strong problem-solving, project management, technical documentation, and communication skills.

Culture & Benefits

• Work with Quality, Manufacturing, Supply Chain, Regulatory Affairs, and supplier stakeholders.
• Support audits and inspections through packaging-related technical expertise and documentation.
• Contribute to products designed to improve patient outcomes through image-guided medical procedures.