Senior Sustaining Manufacturing Engineer

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

Job summary

Selution, in partnership with Cordis, seeks a Senior Sustaining Manufacturing Engineer to drive continuous improvement in a regulated drug-device environment.

You will lead process optimization, CAPA investigations, and data-driven improvements across manufacturing, quality, R&D, and supply chain while mentoring teams and ensuring compliance with GMP and ISO 13485.

Qualifications

• Bachelor’s degree in engineering or chemistry with a technical background.
• 5+ years in manufacturing engineering within regulated industries.
• Experience with GMP, ISO 13485, risk management, and change control.
• Data-driven fault analysis and CAPA experience with root cause investigations.

Responsibilities

• Lead sustaining engineering projects to improve yield, quality, and throughput.
• Monitor performance using data trends and KPIs to target improvements.
• Guide CAPA investigations and nonconformance with Quality.
• Apply Lean Six Sigma and problem-solving tools to reduce waste and variation.
• Support validation, IQ/OQ/PQ, and revalidation as needed.
• Maintain technical docs, procedures, and PFMEAs; mentor staff.

Skills

GMP knowledge

ISO 13485

Process validation

Risk management

CAPA investigations

Root cause analysis

Data-driven methods

Technical writing

Communication

Project management

Statistical analysis

Lean Six Sigma

Education

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

Tools

DOE

SPC

Process validation

Job description

Overview

Selution, in partnership with Cordis, specializes in the development of groundbreaking technology and commercialization of advanced drug-device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Responsibilities

The Senior Sustaining Manufacturing Engineer provides technical leadership for sustaining manufacturing operations, with primary responsibility for continuous improvement, process optimization, and long-term process performance. This role leads data-driven initiatives to improve yield, reduce scrap and variation, enhance product quality, and improve manufacturing efficiency. The engineer also provides technical expertise for manufacturing nonconformance and CAPA investigations, including root cause analysis, implementation of sustainable corrective actions, and effectiveness verification. The position partners with Quality, Operations, R&D, and Supply Chain to maintain validated processes and compliance with applicable GMP and ISO 13485 requirements.

Key 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.

Qualifications

Required Qualifications:

• Bachelor’s in Mechanical, Manufacturing, Industrial, Biomedical Engineering, Chemistry or equivalent technical degree.
• 5+ years of manufacturing engineering experience in a regulated industry, including sustaining manufacturing or process improvement responsibilities.
• 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.

Preferred Qualifications:

• Experience with medical device or drug-device combination product manufacturing.
• Lean Six Sigma Green Belt or Black Belt certification and practical application of statistical process improvement tools.
• Experience with process capability analysis, DOE, SPC, and manufacturing performance metrics.
• Experience with automation, equipment reliability improvements, or high-volume assembly systems.

Key Competencies

• Continuous improvement leadership and results-oriented execution.
• Data analysis, structured root cause investigation, and evidence-based decision-making.
• Technical ownership of sustaining process performance and CAPA effectiveness.
• Cross-functional collaboration, mentoring, and practical manufacturing problem-solving.
• Commitment to product quality, regulatory compliance, and operational excellence.

Working Conditions

• Office, laboratory, and manufacturing floor environments.
• Regular standing or walking, occasional lifting up to 25 lbs.
• Must comply with GMP, ISO 13485, and all EHS requirements.

Pay / Compensation

The expected pre-tax pay rate for this position is $97,900 – $130,900. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.