Engineer, Manufacturing Engineering

Stryker • Irvine, CA

15h • Onsite

About The Position

The Manufacturing Engineering will support sustaining engineering activities to ensure safe, compliant, and efficient manufacturing of medical devices. This role will be responsible for driving continuous improvement, troubleshooting production issues, and supporting change management activities while ensuring adherence to internal quality system requirements. The role partners closely with Operations, Quality, R&D, and Suppliers to improve yield, optimize processes, and support product lifecycle objectives.

Requirements

• Bachelor’s degree in mechanical engineering, biomedical engineering, or related discipline.
• 0 years of Medical Device experience.

Responsibilities

• Execute process validation activities, IQ/OQ/PQ for manufacturing processes, equipment, and test methods to ensure continued compliance and product quality.
• Develop, author, review, and approve validation protocols, reports, and supporting manufacturing documentation meeting internal quality system requirements.
• Support assessment of implementation of revalidation strategies driven by process changes, non-conformances, CAPAs, production metrics trends or continuous improvement initiatives.
• Troubleshoot manufacturing production and equipment issues related to existing establish processes and directly work with cross functional team members to implement corrective actions.
• Directly support management activities that will include performing risk assessments, impact on validated processes and products, equipment, and material changes.
• Support Quarantine Ticket (QT) and Non-conformance (NC) report dispositions and investigations.
• Support Kaizen and continuous improvement events.
• Participate in internal / external audits by providing validation expertise and provide general guidance on existing manufacturing processes.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level