Packaging Engineer

Argon Medical Devices Inc; Athens (TX); Sur place; USD 70 000 - 110 000; Plein temps

Résumé du poste

Argon Medical Devices Inc is seeking a Packaging Engineer to oversee packaging operations and ensure compliance with regulatory requirements. You will lead IQ/OQ/PQ activities, validate packaging processes, and manage CAPAs and change controls.

The role requires 3–5 years in packaging engineering within a regulated manufacturing environment, preferably medical devices, and knowledge of ISO 11607, ISO 13485, and FDA QSR. SolidWorks is a plus, with focus on quality and continuous improvement.

Qualifications

• Bachelor's degree in Packaging Engineering or related technical field.
• 3–5 years of packaging engineering experience in a regulated manufacturing environment (medical devices preferred).
• Experience with process validation, equipment qualification, change control, and CAPA systems.
• Knowledge of packaging equipment, materials, and design software (SolidWorks).
• Familiarity with FDA Quality System Regulation, ISO 13485, and ISO 11607 requirements.

Responsabilités

• Lead packaging process and equipment qualifications (IQ, OQ, PQ).
• 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 and evaluate impact of changes.
• Provide technical support to manufacturing operations and troubleshoot packaging 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 to enhance quality, efficiency, and cost performance.
• Ensure packaging processes and deviations comply with quality and regulatory requirements.
• Maintain packaging specifications, validation records, and engineering documentation.

Connaissances

Packaging engineering

Process validation

Regulatory compliance

Documentation skills

SolidWorks

Project management

Formation

Bachelor's degree in Packaging Engineering

Outils

SolidWorks

Description du poste

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, anddesign 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.