Sr Packaging Engineer Exempt

Join a dynamic team that provides expertise in packaging engineering ensuring quality and regulatory compliance. This role supports and leads projects collaborating with stakeholders to achieve desired results. Located in the beautiful city of Lafayette CO this position offers a unique opportunity to work in a thriving community with stunning mountain views and a vibrant local culture.

Key Responsibilities

• Evaluate the current state of various medical device product packaging design and perform gap analysis according to ISO11607 Part 1 and 2.
• Generate and execute packaging remediation plans for sterile barrier systems and non-sterile medical device packaging.
• Lead successful validation of packaging systems for medical devices.
• Identify and develop innovative packaging processes and designs as part of a cross-functional team.
• Utilize quality and regulatory compliance knowledge to support regulatory body audits and draft technical responses.
• Lead project meetings and provide updates to management.
• Assist in the labeling development process.
• May perform and evaluate testing in a laboratory environment as per industry standards.

Minimum Requirements

• Bachelor of Science Degree in Packaging Science Mechanical Engineering or similar discipline.
• Minimum of 5 years in the medical device or pharmaceutical industry in Packaging or Quality Engineering.
• Knowledge and general understanding of ISO 11607 part 1 and 2 ASTM and ISTA package test methods.
• Proficiency in Microsoft Office programs.
• CAD/CAPE/TOPS Software knowledge is preferred.

Additional Responsibilities

• Design develop and test a wide variety of containers used for the protection display and handling of products.
• Determine packaging specifications according to the nature of the product cost limitations legal requirements and the type of protection required.
• Design package exteriors considering factors such as product identification sales appeal and aesthetic quality.
• May include documentation management and/or coordination of Good Manufacturing Practices (GMPs).
• Support prototype line development in manufacturing facilities/plants.

This role is perfect for a seasoned individual contributor who works independently under limited supervision with responsibility for entire projects or processes within the job area. You will have the opportunity to innovate communicate with senior internal and external customers and potentially provide guidance and training to other employees.

Required Experience:

Senior IC