SAN DIEGO, CA
Job Title: Senior Packaging Engineer
Location: San Diego, CA 92121
Pay: $40-70/hr.+ DOE
Duration: Temp to Hire
In this role as a Sr. Packaging Engineer, you will use sound and proven engineering principles, best practices and concepts to assist in designing robust product packaging to ensure product & package integrity is maintained throughout shipping and distribution environment. You will be testing, analyzing, and selecting materials for packaging based on durability and cost effectiveness. Working as a member of a packaging engineer team, you will collaborate and communicate with other engineers, management, and operators.
• Design, development and qualification of primary, secondary, and tertiary robust packaging system for new company products.
• Lead validation & verification of packaging design, processes and equipment to support clinical trials and new product commercialization.
• Implement changes to commercial packaging systems as necessary to support corporate objectives. This typically includes identifying requirements, gaining multi-department buy-in, communicating with vendors, creating and updating documentation, and processing through document control system.
• Communication and collaboration with packaging vendors on new designs, tooling, and qualification. This includes, as necessary, identifying and onboarding new/secondary suppliers.
• Provide technical assistance in scaling up equipment and processes from prototype to pilot to high speed automation manufacturing.
• Develop and maintain technical project timelines and provide updates and feedback to project and R&D Packaging leadership.
• Provide technical oversight and coordinate R&D builds within a pilot production facility for multiple projects and project teams.
• Develop Packaging design requirement flow down, project risks and track mitigations through standard methods.
• Exercise judgment within defined procedures and policies to determine appropriate action.
• This position assumes and performs other duties as assigned.
• B.S. in Packaging Engineering or Mechanical Engineering or equivalent with 5 years related experience or M.S. in Packaging Engineering or Mechanical Engineering or equivalent with 3 years related experience in an FDA regulated environment preferably in Medical Device/Pharma.
• Knowledge of Design for Six Sigma and/or Lean Six Sigma will be a plus.
• Demonstrated ability to design, develop and implemented packaging system for sterile and non-sterile per ISO 11607-1/2, ASTM & EN standards.
• Proficiency with Medical Device development life cycles and packaging design, processes and technologies preferred.
• Exceptional technical writing skills through experience drafting study protocols and reports, validation protocols and reports, & technical analysis.
• Demonstrated ability to run self-directed projects, maintain timelines, and execute projects in an R&D environment.
• Detail knowledge of selecting materials for sterile and non-sterile packaging systems including ESD protection.
• Previous experience in FDA regulated industry and high-speed automation experience.
• Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things.
• Excellent communication (written and verbal) and personal interaction skills.
• Familiar with sterile barriers and various sterilization methods (Ethylene Oxide, E-Beam, Gama)
• Self-starter with demonstrated efficient work methods, analytical & problem-solving skills and ability to handle multiple tasks in a fast-paced environment.
• Proficient in the use of Esko ArtiosCAD and Cape Palletization Software SolidWorks or equivalent CAD software.
• Familiar with data analysis methods and analysis software, experience in JMP or Minitab preferred.