Atec Spine Carlsbad , CA 92008
Posted 2 months 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.
Atec Spine