Packaging Engineer — Medical Devices Process Lead

Argon Medical Devices, Inc.; Athens (TX); On-site; USD 75,000 - 105,000; Full time

Job summary

Argon Medical Devices, Inc. in Plano, Texas seeks a Packaging Engineer to lead qualification and validation of packaging processes and equipment, ensuring compliance with FDA QSR, ISO 13485, and ISO 11607.

You will collaborate with Quality, Manufacturing, Supply Chain, Regulatory Affairs and suppliers to drive continuous improvement, manage CAPAs and change controls, and maintain robust packaging documentation for audits.

Qualifications

• Bachelor's degree required in packaging, mechanical, or materials engineering.
• 3-5 years in packaging engineering within regulated manufacturing.
• Experience with validation, qualification, CAPA, and change control.

Responsibilities

• Lead packaging process and equipment qualifications (IQ/OQ/PQ).
• Develop and document validation protocols and reports.
• Manage packaging CAPAs and investigations.
• Support change control and supplier changes.
• Provide technical support to manufacturing operations.
• Drive continuous improvement in quality and cost.
• Maintain packaging specifications and engineering documentation.

Skills

Packaging process

Process validation

Equipment qualification

CAPA management

Technical documentation

FDA QSR knowledge

ISO 13485

Education

Bachelor's in packaging or related

Tools

SolidWorks

MS Office

Minitab

Job description

Argon Medical Devices, Inc. in Plano, Texas seeks a Packaging Engineer to lead qualification and validation of packaging processes and equipment, ensuring compliance with FDA QSR, ISO 13485, and ISO 11607.

You will collaborate with Quality, Manufacturing, Supply Chain, Regulatory Affairs and suppliers to drive continuous improvement, manage CAPAs and change controls, and maintain robust packaging documentation for audits.