Senior Sustaining Manufacturing Engineer - CI Lead

Cordis; Irvine (CA); On-site; USD 98,000 - 131,000; Full time

Job summary

Cordis is seeking a Senior Sustaining Manufacturing Engineer in Irvine, CA, to lead continuous improvement and sustaining projects across manufacturing operations. You will drive process optimization, CAPA investigations, and data-driven improvements to yield, quality, and efficiency, partnering with Quality, R&D, and Supply Chain.

The role requires deep GMP/ISO 13485 knowledge, hands-on problem solving, and mentoring of engineers.

Qualifications

• Bachelor’s in Mechanical, Manufacturing, Industrial, Biomedical Engineering, Chemistry or equivalent technical degree.
• 5+ years of manufacturing engineering experience in a regulated industry.
• Working knowledge of GMP, ISO 13485, process validation, risk management, and manufacturing change control.
• Demonstrated experience with manufacturing nonconformance investigations and CAPA processes, including root cause analysis, corrective action implementation, and effectiveness verification.
• Demonstrated success using data-driven methods to improve manufacturing processes, yield, quality, or operational efficiency; strong technical writing, communication, and project management skills.

Responsibilities

• Lead continuous improvement and sustaining engineering projects to improve manufacturing yield, product quality, throughput, process capability, and cost performance.
• Monitor manufacturing performance using process data, trends, and key metrics; identify recurring losses and prioritize measurable process improvements.
• Lead manufacturing process optimization activities, including structured experimentation, statistical analysis, and evaluation of process changes.
• Provide technical leadership for manufacturing-related nonconformance investigations, including product and process impact assessments, root cause analysis, and appropriate disposition support in partnership with Quality.
• Lead or support CAPA investigations for manufacturing issues; develop and implement corrective and preventive actions, assess systemic risk, and verify effectiveness.
• Apply Lean, Six Sigma, and structured problem-solving tools to reduce waste, defects, scrap, rework, and process variation.
• Troubleshoot recurring equipment and process issues; implement sustainable solutions and appropriate preventive controls.
• Assess proposed process changes for validation, qualification, risk management, and change-control impact; support IQ/OQ/PQ or revalidation as required.
• Maintain and improve manufacturing procedures, work instructions, specifications, process controls, PFMEAs, and related technical documentation.
• Partner with Production, Quality, R&D, and Supply Chain on manufacturing improvements, audit readiness, investigation closure, and sustained process performance.
• Mentor engineers and technicians in investigation methods, data analysis, process troubleshooting, and continuous improvement practices.

Skills

Data-driven decision making

Root cause analysis

CAPA investigations

Process optimization

Cross-functional collaboration

Technical writing

Education

Bachelor’s in Mechanical, Manufacturing, Industrial, Biomedical Engineering, Chemistry or equivalent technical degree

Tools

Lean Six Sigma

DOE

SPC

Job description

Cordis is seeking a Senior Sustaining Manufacturing Engineer in Irvine, CA, to lead continuous improvement and sustaining projects across manufacturing operations. You will drive process optimization, CAPA investigations, and data-driven improvements to yield, quality, and efficiency, partnering with Quality, R&D, and Supply Chain.

The role requires deep GMP/ISO 13485 knowledge, hands-on problem solving, and mentoring of engineers.