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Packaging Engineer II

Irvine, CA 92617

Posted: 11/29/2023 Employment Type: Contract Job Category: Engineering Job Number: 591384 Is job remote?: No Country: United States

Job Description

The manager would like to re-vamp and bring in another round of candidates. He would like to focus more on the below items this time around. Please let me know if you have any additional questions, thank you for your continued support!
Must Haves
  • Understands GDP well – solid protocol / Report, creating pkg specifications and working with change control system (2- 5years exp)
  • Solid understanding of process validations (IQ/OQ/PQ) 
  • Solid understanding of pkg performance / design verification testing – (ideally sterile barrier pkg systems, Ideally flexible barriers)
  • Min 2 years in packaging, ideally 3 – 5 years
  • Must be within “commutable” – 2/3 days per week
  • Experience with change orders – release specs, protocols, reports, and position papers Ideal to have but could related could be acceptable
  • Med Device Pkg
  • Sterile pouch systems

HM's Top Needs:
  1. Ability to work well in a dynamic, fast paced work environment.
  2. Higher degree of initiative and self-motivation.
  3. BS in Packaging or a related engineering field (i.e. Mechanical, Biomedical, Materials)

Education Required:  BS in Packaging or a related engineering field (i.e. Mechanical, Biomedical, Materials)

Years’ Experience Required:  Minimum 4 years of experience


Will the contractor be working 40 hours a week?  yes If not, weekly estimate?

Work Location: Irvine Calif

                Do they need to be local to any MDT office and if so where? Yes.  within a commutable distance.

Does this person need to be on site? If so, full time or part time? flex work 2 – 3 days per week onsite and as needed

Responsibilities include supporting New Product Development and Released Product projects focusing on Packaging.  This individual will be responsible for leading and executing the completion of packaging engineering milestones for assigned projects as well as the design and development of innovative packaging systems for devices still in concept.  The role interacts frequently with cross functional resources such as Program Managers, other cross functional teams (Design Lead, Marketing, Process Development, Manufacturing Operations (internal and external), Regulatory, and Quality/Design Assurance. 
  • Serve as a subject matter expert on cross-functional project teams focusing on design, technology and process.
  • Develop technical design documentation including design plans, input requirements, validations and technical reports in accordance with quality system requirements.
  • Utilize knowledge of FDA and ISO requirements related to packaging, ensuring robust package validation and qualification.
  • Prepare packaging validation protocols and reports to support packaging changes.
  • Perform packaging validation testing to support changes.
  • Utilize project management skills to gain alignment and maintain project schedules.
  • Prepares monthly progress reports on projects.
  • Provides work direction to lab technicians as required.
  • Assists in mentoring of junior engineers.

Must Have
  • BS in Packaging or a related engineering field (i.e. Mechanical, Biomedical, Materials)

Nice To Have
  • Ability to effectively communicate and work cooperatively with others as a lead member of a team
  • Ability to work well in a dynamic, fast paced work environment
  • Effective problem-solving skills
  • Excellent written and verbal communication skill
  • Experience working in business systems including Excel and other Microsoft Office programs
  • Higher degree of initiative and self-motivation
  • Highly detail oriented
  • Minimum 1 year experience leading package engineering projects/deliverables
  • Minimum 4 years of packaging engineering experience in the Medical Device or Pharmaceutical Industry
  • Packaging experience preferred
  • Solid project management skills
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