Sustaining Manufacturing Engineer II

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

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.

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 Sustaining Manufacturing Engineer II provides technical leadership for sustaining manufacturing operations, with primary responsibility for continuous improvement, process optimization, and long-term process performance. This role aids data-driven initiatives to improve yield, reduce scrap and variation, enhance product quality, and improve manufacturing efficiency. The engineer also provides support 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

• Contribute to 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.
• Help in manufacturing process optimization activities, including structured experimentation, statistical analysis, and evaluation of process changes.
• Provide technical support for manufacturing‑related nonconformance investigations, including product and process impact assessments, root cause analysis, and appropriate disposition support in partnership with Quality.
• 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.

Qualifications
Required Qualifications:

• Bachelor’s in Mechanical, Manufacturing, Industrial, Biomedical Engineering, Chemistry or equivalent technical degree.
• 2+ 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 experience and results‑oriented execution.
• Data analysis, structured root cause investigation, and evidence‑based decision‑making.
• Technical knowledge 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 $78,650 – $105,600. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job‑related knowledge and location.

Preferred Qualifications
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work‑authorized visa.

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, and they share a passion for improving people's lives. Diversity not only includes race and gender identity but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammates’ points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable, and welcoming.