Unknown Company

Senior Manufacturing Engineer

irvine, ca • Posted 5 days ago
Onsite Full Time Engineering

*This role will be Monday-Friday on second shift (3 pm - 12 am PST) with some flexibility on the hours. *

Join a team focused on delivering high-quality medical devices through robust manufacturing processes and continuous improvement. In this role, you will support manufacturing operations by applying engineering principles to materials, products, equipment, and processes while maintaining a strong commitment to patient safety, product quality, and regulatory compliance. This position offers the opportunity to work across product development, process improvement, validation, and production support activities in a collaborative manufacturing environment.

What You Will Do

  • Design and improve manufacturing processes, equipment, tooling, and fixtures to support safe, efficient, and compliant production operations.

  • Execute qualification, verification, and validation activities for manufacturing processes and equipment, ensuring compliance with quality and regulatory requirements.

  • Analyze manufacturing data, conduct statistical studies, and troubleshoot issues impacting product quality, yield, cost, delivery, or process performance.

  • Lead and document engineering tests, experiments, and process improvement projects, including data analysis, reporting, and implementation of corrective actions.

  • Collaborate with production teams, technicians, suppliers, and cross-functional project teams to support production goals, project timelines, and continuous improvement initiatives.

What You Will Need

Required:

  • Minimum 2 years of manufacturing engineering experience.

  • Bachelor’s degree in Engineering or a related technical discipline.

  • Experience conducting statistical, geometric, and mathematical analysis in a manufacturing environment.

  • Experience creating, reading, and interpreting engineering drawings usingComputer Aided Design (CAD) software.

  • Proficiency with Microsoft Office applications.

  • Experience supporting process validation, qualification, or verification activities.

  • Support and drive Quarantine Ticket (QT) and Non-conformance (NC) report dispositions and investigations.

  • Mentor entry to junior engineers and provide technical guidance

Preferred:

  • Experience using Minitab or similar statistical analysis software.

  • Experience sourcing, evaluating, or managing external suppliers and service providers.

United States of America Pay Ranges:

$89,400 - $148,900 USD Annual

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