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Senior Packaging Engineer

SAN DIEGO, CA

Order: 226336
Temp - > 30 Hrs

Job Title: Senior Packaging Engineer

Location: San Diego, CA 92121

Pay: $40-70/hr.+ DOE

Duration: Temp to Hire

 

Position Summary:

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.

 

Responsibilities: +

• 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.

 

Qualifications:

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.