Job Description

This role will be responsible for overall package engineering and sterilization related support for new product development and operations teams. As a Sr. Packaging Engineer, the candidate will be a subject matter expert in the development of advanced packaging for sterile & non-sterile medical devices, biologics, capital equipment, assemblies, and associated components. The role will 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

• Responsible for NPI and sustaining packaging projects to meet company goals.
• Responsible for the development and qualification of sterilization protocols and procedures.
• Interface with product development teams to design, prototype, and qualify new packaging solutions.
• Provide sterilization and biocompatibility technical expertise during new product development activities, process modification studies and failure investigations regarding impact to product and validated sterilization cycles.
• Creation, Routing, and Approval of Engineering Change Orders.
• Drive packaging and sterilization efficiencies, cost savings, and continuous process improvements through the application of six sigma, 5S, and lean manufacturing.
• Support and provide assurance that sterilization programs are aligned with broader risk management processes, addressing package stability-related risks and risks arising from the sterilization process from both a product and patient safety perspective.
• Support contract manufacturing in performing equipment IQ, OQ, and PQ.
• Maintain and update packaging and sterilization related SOP’s, FRM’s, Standards, and Work Instructions.
• Responsible for the development and execution of test methods, validations, and protocols for packaging and sterilization.
• Ensure adherence to the requirements of ISO 11607, ISO 11137, ISO 11135, ASTM D4169 and other related standards to internal and external stakeholders.
• Work with external sterilization partners to characterize and determine optimal sterilization processing parameters.
• Provide technical guidance and mentorship to more junior packaging engineers.
• Maintains up-to-date knowledge of the latest industry trends and regulatory changes.
• Ability to investigate complex sterilization challenges and identify opportunities for optimization.
• Other duties as assigned.

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.

• Comprehensive knowledge of packaging and sterilization standards, as well as medical device guidelines, such as ISO 13485, ISO 11607, ISO 11137, ISO 11135, and ASTM D4169.
• Advanced knowledge of medical device packaging i.e. design, materials, adhesives, processes, and equipment to provide technical solutions.
• Proficiency in SolidWorks to create packaging concepts and drawings.
• Experienced with IQ/OQ/PQ related to packaging processes.
• Experienced with distribution testing and packaging validation equipment (environmental chambers, bubble leak testers, etc.).
• Ability to manage projects from inception to completion with minimal oversight.
• Ability to demonstrate technical knowledge and communicate with internal and external customers.
• 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.
• 5-8 years of experience in packaging and sterilization of medical devices.
• Certified Packing Professional (CPP) preferred.

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. $120,000 to $135,000 Full-Time Annual Salary

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