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Manufacturing Engineer

Vir Healthway - Irvine, CA

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Job Description

Perform Gap Assessment - Equipment on the floor, Gap Assessment / review on existing change control Process & Documents. Create / update the manufacturing procedures. Develops and executes Engineering studies and Process validation protocols and Summary reports (Installation Qualification, Operation Qualification, Process Qualification and Test Method Validation) Vendor Coordination to source equipment. Perform TMV / Protocol / Execution / Report Perform FAT. SOP (Standard Operating Procedure) create / update as needed. Fixture design, development and verification. Process improvements as needed Working independently with the internal and external stakeholders for execution. Prepare reports, presentations, and spreadsheets of an analytical and interpretative nature. Collaborate with peers to manage the development of appropriate testing to verify product meets internal and external customer requirements. Maintain accountability to the completion of specific programs and projects in accordance to agreed project deliverables. Use advanced techniques to anticipate, identify and develop solutions or alternatives to a variety of common and uncommon problems having a range of complexity. Provide leadership, training, and mentorship to less experienced team members. Demonstrated ability to manage and prioritize multiple tasks/projects with a strong problem-solving ability.

Created: 2026-04-02

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