Job Summary:

The Packaging Engineer is responsible for designing, developing, and implementing packaging solutions for orthopedic products, ensuring their safe transportation, storage, and sterility maintenance. This role involves collaborating with cross-functional teams, working with suppliers and test houses to conduct packaging tests, and ensuring compliance with regulatory requirements and industry standards.

Responsibilities:

• Collaborate with R&D, engineering, and design teams to develop packaging concepts that protect medical devices during distribution and storage.
• Design packaging solutions considering device size, shape, material compatibility, and regulatory requirements.
• Create detailed packaging specifications, drawings, and prototypes.
• Evaluate and select packaging materials, including barrier films, seals, trays, and labels.
• Perform packaging material compatibility tests and studies, considering factors like biocompatibility and sterilization methods.
• Conduct accelerated aging and stability studies to assess the packaging’s durability and performance over time.
• Plan and execute packaging validation studies with test houses, including integrity testing (e.g., leak testing, seal strength testing) and transportation simulation. Provide clear and concise reports on packaging development, testing, and validation activities.
• Analyze test results and make recommendations for design modifications or improvements.
• Work closely with manufacturing, quality assurance, and supply chain teams to ensure packaging processes are aligned with production requirements.
• Communicate packaging specifications and requirements to suppliers and manufacturers.
• Identify opportunities for cost savings, efficiency improvements, and waste reduction in the packaging process.
• Maintain accurate and up-to-date packaging-related documentation, including design history files, validation reports, and technical drawings.

Qualifications:

• Bachelor’s or higher degree in packaging engineering, materials science, biomedical engineering, or a related field.
• Solid understanding of medical device packaging regulations and standards, including ISO 11607.
• Experience with packaging design software and tools (e.g., SolidWorks).
• Proficiency in conducting packaging testing and validation activities.
• Knowledge of sterilization methods and their impact on packaging materials.
• Strong problem-solving skills to address packaging-related challenges.
• Excellent communication skills to collaborate with cross-functional teams and external partners.
• Attention to detail and a commitment to maintaining the highest quality standards.
• Previous experience in the medical device or pharmaceutical industry is a plus.