Packaging Engineer - Medical Devices

Job ID: 618958

Our client, a leading Medical Device company, is seeking an experienced Packaging Engineer for their North Haven, CT location. Please note that this role is required to be hybrid onsite 3 days/week. See below for other details!

Top 3 Skills/Duties:

1. Leads successful validations of packaging systems for medical devices
2. Able to conduct Packaging systems Gap Analysis according to ISO11607 Part 1 and 2
3. Lead project meetings and provide updates to management

Job Description:

• 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.
• 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.