Sustaining Manufacturing Engineer II: Process Improvement

Cordis, LLC

Irvine (CA)

On-site

USD 79,000 - 106,000

Full time

2 days ago

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Job summary

Cordis, LLC is seeking a Sustaining Manufacturing Engineer II to lead continuous improvement initiatives and sustain critical manufacturing processes for medical-device related products. You will partner with Quality, Operations, R&D, and Supply Chain to optimize yield, reduce scrap, and maintain validated processes in a GMP/ISO 13485 environment.

The role emphasizes data-driven problem solving, CAPA investigations, and robust documentation.

Qualifications

Bachelor's degree required in a technical field; manufacturing experience preferred.
2+ years in regulated manufacturing engineering or sustained manufacturing.
Knowledge of GMP, ISO 13485, validation, risk management, and change control.
Experience with CAPA, root-cause analysis and data-driven process improvements.
Strong writing, communication, and project management skills.

Responsibilities

Lead sustaining manufacturing projects to improve yield, quality, throughput, and cost.
Monitor process performance using data and KPIs to identify chronic losses and drive improvements.
Support structured experimentation and statistical analysis for process changes.
Provide CAPA support, including root cause analysis and corrective actions with verification.
Assist with validation/qualification and change-control activities as needed.
Collaborate with Quality, Operations, R&D, and Supply Chain to ensure compliant processes.