Sterile Packaging Engineer

3 weeks ago

Kansas City, United States The Judge Group Full time

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.

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