Senior Packaging Engineer

Sr. Packaging Engineer

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.