Senior Packaging Development Engineer

Summary:
The Sr. Packaging Engineer provides technical leadership for packaging development and validation, ensuring products meet quality and regulatory requirements while driving process improvements and supporting cross-functional initiatives.

Roles & 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.
• 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.

Education & Experience:

• Bachelor's degree in engineering
• 5+ years of medical device or pharma packaging experience
• Validation of Packaging Systems
• Gap Analysis
• ISO11607
• Ability to conduct Packaging systems Gap Analysis according to ISO11607 Part 1
• Experience leading project meetings