Manufacturing Engineer

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Full Time Fremont, CA, US

Salary Range: $97,000.00 To $ Annually

The Manufacturing Engineer (ME) will be responsible for optimizing manufacturing processes to ensure efficient, high-quality production while maintaining compliance with standards and regulations. The ME will be expected to solve mechanical, electrical, and optical issues seen during the production of opto-electro-mechanical instruments, reduce downtime, lead projects, contribute new ideas, and find innovative methods to accomplish production goals.

• Develop and update work instructions, process documentation, and standard operating procedures.
• Design, develop, and optimize manufacturing processes, workflows, and production layouts.
• Improve production efficiency, reduce waste, and support cost-reduction initiatives.
• Select, install, qualify, and maintain manufacturing equipment, fixtures, and tooling.
• Ensure manufacturing processes meet quality, safety, and regulatory requirements.
• Troubleshoot production issues and implement corrective and preventive actions.
• Support new product introduction, process transfers, and production ramp-up activities.
• Collaborate with engineering design, quality, supply chain, and manufacturing teams.
• Improve product quality by leading root cause investigations and implementing Poka-Yoke solutions to reduce recuring manufacturing defects.
• Implement Lean manufacturing strategies and process enhancements to reduce labor hours per unit, improve throughput, shorten lead times, and decrease field installation.
• Analyze production data, yields, cycle times, and downtime to identify improvement opportunities.
• Lead or support Lean, Six Sigma, and other continuous improvement projects
• Reduce equipment downtime and increased manufacturing output through technician training, coaching, and proactive problem-solving initiatives.
• Prepare and maintain required documentation for assigned duties, including validations, operating procedures, preventive maintenance schedules, engineering change notifications, spare parts lists, and related records.

• Bachelor’s degree in Manufacturing, Electrical, Mechanical, Industrial Engineering, or a related field, with 3+ years of experience supporting system integration, manufacturing, assembly, and test in manufacturing operations.
• Experience in medical device manufacturing and familiarity with associated regulatory and quality requirements.
• Ability to read and interpret engineering drawings, specifications, and technical documents.
• Strong analytical, troubleshooting, and problem-solving skills.
• Knowledge of Lean manufacturing, Six Sigma, root cause analysis, and process validation.
• Strong written and verbal communication skills, teamwork and project management skills.
• Familiar with CAD tools, manufacturing documentation and production data analysis
• Demonstrated ability to design, execute, and analyze experiments, translate data into actionable insights, and provide recommendations that improve product quality, process capability, and operational efficiency.

• Six Sigma Green Belt or Black Belt certification preferred, with demonstrated application of Lean and continuous improvement methodologies.
• Knowledge of Design for Manufacturing and Assembly
• Knowledge of PCBA assemblies, laser systems, optics, fluidics, and electromechanical systems is highly desirable.
• Familiarity with ERP/MRP systems, statistical process control, and manufacturing metrics.
• Working knowledge of ISO 13485 and quality management systems within regulated…