Senior Sustaining Manufacturing Engineer

Cordis•Irvine, CA

About The Position

The Senior Sustaining Manufacturing Engineer provides technical leadership for sustaining manufacturing operations, with responsibility for continuous improvement, process optimization, and long-term process performance. The role leads data-driven initiatives to improve yield, reduce scrap and variation, enhance product quality, and increase manufacturing efficiency. It also provides technical expertise for manufacturing nonconformance and CAPA investigations, including root cause analysis, sustainable corrective actions, and effectiveness verification. The engineer partners with Quality, Operations, R&D, and Supply Chain to maintain validated processes and comply with applicable GMP and ISO 13485 requirements. The position is with Selution, in partnership with Cordis, which develops and commercializes drug-device combination products for coronary and peripheral artery disease. The work takes place in office, laboratory, and manufacturing-floor environments. Regular standing or walking and occasional lifting of up to 25 lbs are required. The employee must comply with GMP, ISO 13485, and EHS requirements.

Requirements

Bachelor’s degree in Mechanical, Manufacturing, Industrial, or Biomedical Engineering, Chemistry, or an equivalent technical degree.
At least 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.

Nice To Haves

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.

Responsibilities

Lead sustaining engineering and continuous improvement projects to improve manufacturing yield, product quality, throughput, process capability, and cost performance.
Monitor manufacturing data, trends, and key metrics to identify recurring losses and prioritize measurable improvements.
Lead process optimization activities, including structured experimentation, statistical analysis, and evaluation of process changes.
Provide technical leadership for manufacturing nonconformance investigations, including impact assessments, root cause analysis, and disposition support with Quality.
Lead or support CAPA investigations, 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 and implement sustainable solutions and preventive controls.
Assess 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.