Packaging Engineer II
5290 California Avenue Irvine, CA 92617 US
Job Description
HM's Top Needs:
- Ability to work well in a dynamic, fast paced work environment.
- Higher degree of initiative and self-motivation.
- BS in Packaging or a related engineering field (i.e. Mechanical, Biomedical, Materials)
Education Required:Â BS in Packaging or a related engineering field (i.e. Mechanical, Biomedical, Materials)
Years’ Experience Required: Minimum 4 years of experience
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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.Â
- 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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