Senior Packaging Development Engineer

Evaluate the current state

• 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

Packaging Remediation

• 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

Validation of Packaging Systems

• Identify and develop innovative packaging processes and designs as part of a cross functional team
• Determine 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

Project Leadership

• Assist in labeling development process