Senior Packaging Engineer

Atec Spine-posted about 1 month ago
Full-time • Senior
Carlsbad, CA
501-1,000 employees
Professional, Scientific, and Technical Services
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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.

  • 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.
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