Job Requirements We 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 standards
Work 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 Qualifications
- Prior 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.
