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- The Principal Packaging Engineer will support our GSC (Global Supply Chain) Packaging Engineer team by providing technical expertise on packaging projects and operations improvement initiatives for medical devices.
- Lead packaging design and development projects for new or improved solutions, full commercial launches, and operations improvement initiatives.
- Lead cross-functional packaging projects across multiple sites/regions with interdepartmental personnel such Regulatory Affairs, Manufacturing, Operations, Quality, Supply Chain among others.
- Create, review, and approve protocols for package design, packaging process validation, and package shelf-life testing in accordance with internal procedures and industry guidelines; may oversee the work of engineers in the development of technical documentation and create goals and objectives for team to support company's KODs.
- Interface with vendors on technical issues and perform duties in compliance with applicable FDA as well as international standards.
- Working knowledge of packaging materials, sterilization methods, test methods, process validation and international standards related to sterile medical device packaging.
- Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
- In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
Principal Engineer, Packaging - Irvine, United States - Edwards Lifesciences Corp
