Sustaining Manufacturing Engineer II — Lean & CAPA Champion

Cordis; Irvine (CA); On-site; USD 79,000 - 106,000; Full time

Job summary

Cordis, in partnership with Selution, seeks a Sustaining Manufacturing Engineer II to drive process improvements for high‑volume medical device production in Irvine. You will lead CAPA investigations, data-driven yield enhancements, and continuous improvement initiatives within GMP/ISO 13485 environments.

Collaborate across Quality, Operations, R&D, and Supply Chain to sustain validated processes and change controls, applying Lean Six Sigma and structured experiments to improve efficiency and

Qualifications

• Bachelor’s degree in a technical field as listed must have.
• Experience in a regulated manufacturing environment; sustaining manufacturing or process improvement.
• Familiarity with GMP, ISO 13485, process validation, risk management, and change control.

Responsibilities

• Contribute to continuous improvement and sustaining projects to improve yield, product quality, throughput, and cost.
• Monitor performance using data, trends, and metrics; identify recurring losses and prioritize improvements.
• Assist with manufacturing process optimization, DOE, and statistical analysis of changes.
• Support nonconformance investigations and CAPA, including root cause analysis and corrective actions.
• Lead CAPA investigations, assess risk, and verify effectiveness of actions.
• Apply Lean and Six Sigma tools to reduce waste, defects, and variation.
• Troubleshoot equipment/process issues and implement preventive controls.
• Assess validation impact of changes and support IQ/OQ/PQ or revalidation as needed.
• Maintain and improve procedures, work instructions, specs, process controls, PFMEAs, and related docs.
• Collaborate across Production, Quality, R&D, and Supply Chain on improvements and audits.

Skills

Data analysis

Root cause analysis

CAPA processes

Process improvement

Project management

Technical writing

Education

Bachelor’s in Mechanical/Manufacturing/Industrial/Biomedical Engineering or Chemistry

Job description

Cordis, in partnership with Selution, seeks a Sustaining Manufacturing Engineer II to drive process improvements for high‑volume medical device production in Irvine. You will lead CAPA investigations, data-driven yield enhancements, and continuous improvement initiatives within GMP/ISO 13485 environments.

Collaborate across Quality, Operations, R&D, and Supply Chain to sustain validated processes and change controls, applying Lean Six Sigma and structured experiments to improve efficiency and