Job Description

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.

Requirements

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Familiar with ISO 13485, FDA Design Control, CAPA, SCAR, and audit procedures
• Experience in packaging engineering, structured problem solving, use of statistical tools, smartsheet and monitoring tools for sterility assurance program.
• Working knowledge of packaging and sterilization standards such as ISO 11607, ISO 11137, ISO 11135, and ASTM D4169.
• Working knowledge of labeling requirements and standards for medical devices.
• Proficient with Solidworks to create packaging concepts and drawings.
• Ability to demonstrate technical expertise and communicate with internal and external customers and executive management.
• Must be deadline-oriented and detail-oriented, an effective communicator, and able to work within a team environment.

Education and Experience

• Bachelor’s degree from four-year College or university in Packaging Engineering or Manufacturing Engineering.
• 1-3 years’ experience in medical device environment.

For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.

Salary Range

Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate’s qualifications, education, skill set, years of experience, and internal equity. $75,000 to $95,000 Full-Time Annual Salary

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