Senior Manufacturing Engineer

Senior Manufacturing EngineerJohnson & 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.Key Responsibilities: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 modifications, failure analysis, and production troubleshooting.Apply statistical analysis tools to evaluate process capability, variation, and manufacturing performance.Communicate project progress, business opportunities, and operational risks to the Leadership Team while ensuring compliance with corporate policies and applicable regulations.Qualifications:Bachelor's degree in Electrical, Mechanical, Chemical, Biomedical, or related Engineering discipline.4–6 years of engineering experience, preferably within a regulated manufacturing environment.Experience leading engineering and capital equipment projects.Knowledge of manufacturing processes, equipment testing, and process validations.Required Skills:Strong knowledge of Root Cause Analysis, FMEA, CAPA, NCR, and continuous improvement methodologies.Experience with project management and cross-functional team leadership.Understanding of electro-mechanical equipment specification, design, testing, qualification, and implementation.Knowledge of statistical analysis, process capability studies, and statistical software such as Minitab.Excellent written and verbal communication skills.Strong organizational, analytical, and problem-solving abilities.Ability to manage multiple priorities in a fast-paced manufacturing environment.Proficiency with Microsoft Office, MS Project, AutoCAD, and/or SolidWorks.Preferred Qualifications:Experience in GMP/ISO regulated manufacturing.Six Sigma certification (Green Belt or Black Belt).Experience with robotics, automation, machine controls, PLCs, and SCADA.Knowledge of lean manufacturing and continuous improvement methodologies.Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request accommodation, please contact us via or contact AskGS to be directed to your accommodation resource."If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent's consent for the background check."Required Skills: Accelerating, Analytical Reasoning, Coaching, Communication, Facility Management, Good Manufacturing Practices (GMP), Lean Manufacturing Principles, Lean Supply Chain Management, Manufacturing Engineering, Manufacturing Science and Technology (MSAT), Problem Management, Project Engineering, Project Schedule, Report Writing, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy