Industrial Engineer
$75,000–$120,750 year
On-siteSanta Clara, California, United States
Job Summary
Support manufacturing systems, process improvement, capacity planning, and layout design initiatives across New Product Introduction and sustaining operations for electro-mechanical and robotic medical device assembly. Perform takt time, cycle time, and capacity analyses to support production volume while applying Lean methodologies and data-driven analysis to improve productivity and operational performance. Assist in developing manufacturing processes, fixtures, and automation solutions, and conduct time studies, value stream mapping, and root cause investigations to reduce cost and lead time. Collaborate with cross-functional teams to support product launches, process transfers, and manufacturing readiness activities, ensuring compliance with medical device regulations and quality system requirements.
Required Qualifications
- Bachelor of Science degree in Industrial Engineering, Mechanical Engineering, Manufacturing Engineering, or related technical field
- 2-4 years of industrial, manufacturing, or operations engineering experience in a regulated or high-volume manufacturing environment
- Knowledge of industrial engineering fundamentals including time studies, line balancing, capacity planning, labor analysis, and process flow optimization
- Experience supporting manufacturing process development, validation activities, or continuous improvement projects
- Familiarity with Lean Manufacturing principles, including 5S, visual management, standardized work, and waste reduction techniques
- Basic understanding of statistical analysis methods including SPC, capability studies, and problem-solving methodologies
- Experience creating or maintaining manufacturing documentation such as work instructions, standard operating procedures, and process flow documentation
- Ability to read and interpret engineering drawings, schematics, and bills of material
- Strong analytical and problem-solving skills
- Effective verbal and written communication skills and ability to work effectively in cross-functional teams
- Proficiency with Microsoft Excel and other data analysis tools
- Ability to travel up to 10% to manufacturing and supplier sites
- May be required to work in cleanroom or classified manufacturing environments and comply with applicable protocols
Desired Qualifications
- Master's degree in Industrial or Manufacturing Engineering
- Preferred Experience within a medical device, life sciences, electronics, or other regulated manufacturing environment
- Familiarity with medical device quality systems and regulatory requirements including GMP and ISO 13485
- Exposure to process validation activities (IQ/OQ/PQ), DOE, and risk assessment tools such as PFMEA
- Knowledge of simulation tools such as FlexSim, Simio, Arena, or equivalent
- Experience with ERP, MES, or PLM systems
- Lean or Six Sigma certification (Yellow Belt or equivalent)
- Exposure to automation, robotics, or electro-mechanical assembly processes
- Familiarity with CAD software for layout development and manufacturing visualization
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