Packaging Engineer

Medical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing resources and expertise to enhance efficiency and productivity. The Packaging Engineer will evaluate packaging designs, lead validations for medical devices, and develop innovative packaging processes while ensuring compliance with industry standards.

Responsibilities:

• Evaluate the current state of various medical device product packaging design; perform gap analysis on existing studies to the latest industry standards such as ISO11607 Part 1 and 2
• Generate and execute packaging remediation plans for sterile barrier systems and non-sterile medical device packaging. Define remediation plans, generate/execute protocols, author closing reports, update specifications and technical documentation
• Lead successful validation of packaging systems for medical devices
• Identify and develop innovative packaging processes and designs as part of a cross-functional team. Determine packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of device protection required
• Utilize quality and regulatory compliance knowledge to support regulatory body audits, draft technical responses, and provide innovative ideas to ensure compliance with the latest industry practices
• Lead project meetings and provide updates to management
• Assist in labeling development process
• May perform and evaluate testing in a laboratory environment as per industry standards
• Designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products
• Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering the need for resistance to external variables such as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering
• Designs package exteriors considering factors such as product identification, sales appeal, aesthetic quality, printing, and production techniques
• Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants

Requirements:

• Bachelor of Science Degree in Packaging Science, Mechanical Engineering, or similar discipline
• Minimum of 5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering
• Practical knowledge and demonstrated competence within packaging engineering typically obtained through advanced education combined with experience
• Knowledge and general understanding of ISO 11607 part 1 and 2, ASTM, and ISTA package test methods is required
• Established and productive individual contributor with strong team and interpersonal skills
• Knowledge of Microsoft Office programs is required
• CAD/CAPE/TOPS Software knowledge is preferred