Manufacturing Engineer

Manufacturing EngineerWe are seeking a hands-on Manufacturing Engineer at our Santa Clara, CA facility. In this role, you will support day-to-day manufacturing execution for custom engineered-to-order (ETO) bioprocess and automated industrial equipment. You will bridge the gap between design engineering and assembly, translating engineering requirements into clear, controlled work instructions, resolving shop-floor technical blockers in real time, driving root-cause problem solving, and ensuring execution discipline from initial assembly through Factory Acceptance Testing (FAT).Primary Job Function:Process & Documentation Development: Translate released engineering drawings, schematics, and BOMs into executable assembly workflows, controlled work instructions, standard work, and travelers.Shop-Floor Technical Support: Provide daily on-floor engineering support to assembly and production personnel; troubleshoot technical, assembly, and process issues during system builds.Engineering Change Implementation: Coordinate with Electrical, Mechanical, Controls, Quality, and Supply Chain teams to resolve manufacturing blockers and ensure Engineering Change Orders (ECOs) are incorporated effectively.Root-Cause Analysis & Continuous Improvement: Identify recurring rework, process variation, and execution inefficiencies; perform root-cause investigations and implement practical corrective actions to improve safety, quality, and throughput.Manufacturing Readiness & FAT Support: Lead manufacturing readiness assessments for upcoming project builds and support downstream integration and Factory Acceptance Testing (FAT) readiness.Training & Compliance: Assist in training and qualifying shop-floor operators on new or updated work instructions in compliance with site safety, quality management system (QMS), and documentation standardsWork Experience:Proven track record creating and updating controlled manufacturing documentation, work instructions, and Standard Work.Demonstrated ability to read and interpret complex engineering drawings, schematics, assembly layouts, and Bills of Materials (BOMs).Strong hands-on production troubleshooting skills paired with structured problem-solving/root-cause analysis techniques (e.g., 5-Why, Fishbone, 8D).Direct experience working within formal change-management and controlled documentation environments (PLM/ERP).Soft Skills: Excellent written and verbal communication skills; strong interpersonal capability to work effectively alongside assembly technicians as well as cross-functional engineering teams.Preferred QualificationsPrior experience with biopharmaceutical process equipment, single-use systems (SUS), piping skids, or comparable regulated manufacturing environments.Practical knowledge of Lean manufacturing principles (5S, Standard Work, waste reduction) and ISO/cGMP quality standards.Qualifications/Experience/Education Requirements:Education: B.S. in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or equivalent practical experience.Experience: 3-7 years of experience in manufacturing, assembly, or process engineering for complex machinery, automated equipment, or custom-engineered systems.