Job Description

Argon Medical 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 compasses 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

The Packaging Engineer plays a critical role in designing, developing, and optimizing packaging solutions for products. Their responsibilities ensure that products are protected during transportation, storage, and handling while also considering factors such as cost, sustainability, and compliance with regulations.

• Operate and monitor packaging equipment, including Form-Fill-Seal (FFS) machines and sealing equipment, ensuring consistent performance and output.
• Troubleshoot equipment and process issues on the manufacturing floor in real-time to minimize downtime.
• Support packaging validation and qualification efforts for manufacturing lines, including IQ/OQ/PQ documentation and execution.
• Conduct line trials for new packaging processes, sealing parameters, or material changes.

• Perform standard packaging tests to verify package integrity and compliance, including:

• • Seal Strength Testing (ASTM F88)
  • Dye Penetration Test (ASTM F1929)
  • Bubble Leak Testing (ASTM F2096)
  • Burst Strength Testing (ASTM F1140)
  • Drop, Compression, and Vibration Testing (ISTA/ASTM standards)
• Maintain and improve packaging process controls to ensure repeatability and compliance with product requirements.
• Review and analyze production data to identify trends, address inefficiencies, and report on key performance indicators.
• Work collaboratively with manufacturing, quality, engineering, and maintenance teams to resolve issues and implement corrective/preventive actions (CAPA).
• Lead investigations into packaging non-conformances and provide technical support for root cause analysis.
• Assist in training production personnel on packaging equipment and process updates.
• Ensure compliance with GMP, ISO, and regulatory guidelines in all packaging operations.
• Support qualification of new or modified packaging equipment and packaging components due to engineering changes or supply chain needs.
• Generate and maintain work instructions, batch records, and technical documentation related to packaging manufacturing.
• Implement lean manufacturing practices to improve efficiency and reduce waste in packaging operations.

Competency Requirements:

• Strong hands-on experience with automated packaging machinery, sealing systems, and related manufacturing equipment.
• Problem-solving mindset with an ability to troubleshoot under pressure.
• Familiarity with validation processes and technical writing for manufacturing documentation.
• Excellent communication and cross-functional collaboration skills.
• Detail-oriented and organized with the ability to manage priorities in a fast-paced production environment.

• Bachelor’s degree in Mechanical Engineering, Packaging Engineering, Industrial Engineering, or a related field.
• 5+ years of hands-on experience in a medical device or regulated manufacturing environment with a focus on packaging operations.
• Knowledge of GMP, ISO 13485, ISO 11607, ASTM/ISTA standards, and validation protocols (IQ/OQ/PQ).
• Familiarity with lean manufacturing and continuous improvement principles.
• Experience using manufacturing execution systems (MES), ERP systems, and data collection tools is a plus.

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