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.
- ssist 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
- bility to conduct Packaging systems Gap Analysis according to ISO11607 Part 1
- Experience leading project meetings
