Packaging Engineer

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

Company Overview

Argon Medical Devices is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compass which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.

ARGON MEDICAL DEVICES IS NOT LEVERAGING SEARCH FIRMS

Position Overview

The Packaging Engineer is responsible for supporting packaging operations through process validation, equipment qualification, change management, and continuous improvement activities. This role provides technical leadership for packaging processes, equipment, and materials to ensure compliance with quality, regulatory, and manufacturing requirements while supporting operational efficiency and product quality.

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, and corrective actions.
• Support change control activities, evaluating the impact of process, material, equipment, and supplier changes.
• Provide technical support to manufacturing operations, including troubleshooting and resolution of packaging-related issues.
• Lead qualification efforts for alternative materials, suppliers, and packaging components to mitigate supply risks.
• Support installation, commissioning, and validation of new packaging equipment.
• Drive continuous improvement initiatives to enhance quality, efficiency, and cost performance.
• Ensure packaging processes and temporary deviations comply with applicable quality system and regulatory requirements.
• Maintain packaging specifications, validation records, engineering documentation, and technical reports.
• Collaborate with Quality, Manufacturing, Supply Chain, Regulatory Affairs, and suppliers to support business objectives.
• Support audits and inspections by providing packaging-related technical expertise and documentation.

Skills for Success

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, Materials Engineering, or related technical discipline required.
• 3-5 years of packaging engineering experience in a regulated manufacturing environment, preferably medical devices required.
• 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, and technical documentation skills.
• Excellent written and verbal communication skills.