Sterile Packaging Engineer
Company: The Judge Group
Location: Kansas City
Posted on: May 4, 2024
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Job Description:
Our client is currently seeking a Sterile Packaging
Engineer.This is a long term contract opportunity requiring of
onsite work in the Kansas City area. Position Overview:
The Sterile Packaging Engineer plays a critical role in ensuring
the quality and safety of medical devices throughout their
lifecycle. Working closely with regulatory, development, and supply
chain partners, this engineer oversees the sterile packaging
process from DHF (Design History File) development to design
transfer of DMR (Device Master Record), manufacturing,
sterilization, and shelf readiness (DHR - Device History Record).
The primary focus is on validating sterile packaging and the
sterilization process, ensuring biocompatibility, and assessing
packaging durability under shelf life and distribution
conditions.Essential Duties and Responsibilities: Collaborate with
cross-functional teams to review Bills of Materials (BOMs) and
Design Failure Mode and Effects Analyses (DFEMAs) during design
transfer. Develop control plans with suppliers, capturing critical
parameters related to sterile packaging risk and capability. Review
all new products, packaging, or process changes to assess potential
risks to sterility and packaging integrity. Ensure that validations
are current, complete, and compliant with medical device standards
at each sterile packaging facility. Review sterile packed product
acceptance documentation and release product by lot. Monitor and
manage biocompatibility aspects in collaboration with product
development, suppliers, and sterile packaging facilities.
Qualification Requirements: 2+ years of experience in the medical
device industry, or specifically working in a sterile packaging
environment, or a Bachelor's degree in Sterile Packaging
Engineering. Skills and Abilities: Proficiency in Microsoft Office.
Self-motivation and project planning experience. Desired
understanding of sterile packaging, quality control, manufacturing,
validation, and statistics.
Keywords: The Judge Group, Olathe , Sterile Packaging Engineer, Engineering , Kansas City, Kansas
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