Packaging Engineer

Atec Spine Carlsbad , CA 92008

Posted 1 week ago

This role will be responsible for overall package engineering, labeling and sterilization related support for new product development teams. As a Packaging Engineer, you will be responsible for development of advanced packaging, labeling and sterilization concepts for sterile & non-sterile medical device, assemblies, and associated components. The role will lead and support cross functional teams such as R&D, operations, Regulatory, Quality and supply chain to drive packaging and sterilization related activities and strategies to improve time to market capabilities for Alphatec products.

Essential Duties and Responsibilities

  • Manages packaging development and improvement projects to meet Company, and regulatory needs.

  • Translates requirements for sterilization standards such as ISO 11137, ISO 11135 and novel sterilization methods to develop sterilization validation plans.

  • Develop and maintain routine Dose audit, bioburden and Bacterial Endotoxin testing schedules for sterile implants and disposables.

  • Creates packaging, labeling and sterilization related SOP's and Work Instructions.

  • Translates requirements for ISO 11607-1:2006 requiring packaging for terminally sterilized products to internal product development teams and packaging personnel supporting these operations.

  • Develops and executes test methods, validations, and protocols for packaging, sterilization related developments and projects.

  • Supports packaging, labeling and sterilization related manufacturing issues, CAPA's, SCARS and audits.

  • Develop label bar codes, symbiology, and labeling processes when appropriate.

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