MDR - Packaging Engineer

Title: MDR - Packaging Engineer

Location: Boulder, CO

Duration: 12 Months


Candidate must be local to Boulder, CO and work on site.

Top skills/experience needed:

Experience in medical device packaging engineering

Experience in EU MDR remediation

The packaging engineer is part of a dynamic team that provides expertise in packaging engineering and ensures quality and regulatory compliance. Supports and/or leads projects and collaborates with stakeholders to achieve desired results. Responsibilities include the following:

• 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.

• Leads successful validation of packaging systems for medical devices

• Identify and develop innovative packaging processes and designs as part of a cross functional team. Determines 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 to 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.

Minimum 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.

• Requires 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.

Job Requirements:

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Boulder, CO 80301, US