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Sr Packaging Engineer - Boulder, United States - LanceSoft
Description
Must Have:1.Design and development of a packaging system for terminally sterilized medical devices as per requirements established by ISO Part 1:
Requirements for materials, sterile barrier systems and packaging systems) and corresponding packaging ASTM and ISTA (International Safe Transit Association) standards.
2.Validation of processes for packaging medical devices that are terminally sterilized as per requirements established by ISO Part 2:
Validation requirements for forming, sealing and assembly processes). These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. 3. Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS)
Regulation & Medical Device Good Manufacturing PracticesNice to Have:4. Experience with medical devices sterilization methods (i.e., ethylene oxide, radiation, etc.) 5.
Experience implementing appropriate risk mitigation actions with knowledge of packaging or process and process Risk Management as per FDA & ISO standards.
6. Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools. 7. Working knowledge of SolidWorks or other packaging CAD programs (i.e., TOPS, SolidWorks, CREO, etc.). 8. Experience with Minitab or other statistical software.JOB DESCRIPTIONTop 3 technical skills that you are required for this role:
Design, testing and validation of a packaging system for terminally sterilized medical devices as per requirements established by ISO 11607Packaging engineering responsibilities in ISO13485/GMP environmentExperience with medical devices sterilization methods (i.e., ethylene oxide, radiation, etc.)
Education Required:
BS in Packaging Engineering or Packaging SciencesYears'
Experience Required: 5 yearsWill the contractor be working 40 hours a week? If not, weekly estimate? Yes, 40 hours per week.
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? On site.
Boulder, Colorado.What is your timeline for scheduling interviews? 02/ /2024What product line will this person support? General Surgery (i.e., Hand Instruments, Ligation Devices, Hysteroscopy, Staplers, Wound closure, etc.)
ESSENTIAL FUNCTIONS:
Identify and lead cost reduction opportunities (> ***K) in regard to packaging.
Lead and implement packaging design changes when requested for both, sterile and non-sterile components/products.
Provide technical support and training to manufacturing in regard to packaging systems.
Prepare packaging validation protocols and perform testing to support packaging changes.
Lead material qualifications for packaging changes such as resin material changes.
Create and upate packaging specifications for manufacturing.
Assist in artwork creation and revisions for product packaging.
Create sterilization pallet patterns as well as non-sterile pallet patterns for manufacturing locations.
Ensure on time delivery of projectsPrepares monthly progress reports on projects.
