Senior Manufacturing Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Engineering Job Sub Function: Manufacturing Engineering Job Category: Scientific/Technology All Job Posting Locations: Irving, Texas, United States of America Job Description: Johnson & Johnson MedTech is recruiting for a Senior Manufacturing Engineer, to join the team. The location for this position is Irvine, TX. At Johnson & Johnson MedTech, we are driven by a shared purpose to help people live longer, healthier lives. The Aesthetics & Reconstruction (A&R) business delivers innovative solutions across reconstruction, wound closure, breast aesthetics, and plastic surgery, helping healthcare professionals improve patient outcomes and quality of life around the world. Through innovation, collaboration, and a commitment to operational excellence, A&R partners across regions and functions to ensure reliable product supply, exceptional customer service, and sustainable business growth. Learn more about Johnson & Johnson MedTech at https://www.jnjmedtech.com.

Lead capital equipment projects, including equipment specification, design, installation, testing, process qualifications (IQ/OQ/PQ), and implementation while ensuring compliance with GMP, ISO, and regulatory requirements. Design, execute, and document engineering studies, Design of Experiments (DOE), validation protocols, and technical reports. Develop, revise, and maintain production standards, standard work instructions, engineering procedures, and process documentation. Establish and maintain equipment and process standards to improve overall equipment effectiveness (OEE) and manufacturing performance. Analyze manufacturing data using statistical methods to identify trends, improve process capability, and optimize production performance. Manage engineering projects of moderate to high complexity while meeting safety, quality, cost, and schedule objectives. Drive continuous improvement initiatives focused on process optimization, equipment utilization, downtime reduction, waste elimination, yield improvement, and cost savings. Provide technical leadership in resolving manufacturing issues by conducting root cause analysis, implementing corrective and preventive actions (CAPA), and supporting cross-functional investigations. Manage Non-Conformance Reports and CAPA activities through closure, ensuring timely resolution and regulatory compliance. Ensure adherence to Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Data Integrity (DI) requirements. Develop, update, and maintain engineering, equipment, and process related documentation. Support internal and external GMP audits by maintaining equipment records and demonstrating compliance with quality standards. Collaborate with equipment manufacturers, suppliers, and internal stakeholders to improve equipment reliability and manufacturing efficiency. Develop, implement, and maintain equipment and process procedures. Promote a safe work environment by complying with Johnson & Johnson safety policies and regulatory requirements. Provide engineering support for process improvements, equipment