Packaging Engineer

We are seeking a Packaging Engineer for a very important client.

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 EU MDR packaging remediation 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 EU MDR 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 1-3 years in medical device or pharmaceutical industry in Packaging or Quality Engineering.

· Established and productive individual contributor with strong team and interpersonal skills.

· 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 preferred.

· Knowledge of Microsoft Office programs is required.

CAD/CAPE/TOPS Software knowledge is preferred.

Top 3 technical skills that are required for the role:

1. Knowlege and working experience in Medical Device Package Design and qualification

2. Understanding of Packaging Engineering Industry Standards and regulations (i.e. ISO 11607-1,-2)

3. Experience in regulated industry, medical devices or pharmaceutical

Education Required: Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline

Years’ Experience Required: Minimum of 3-5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering