Manufacturing Engineer in Fremont, California at Cytek Biosciences Inc

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• 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.

REQUIRED SKILLS & QUALIFICATIONS:

• 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.

PREFERRED QUALIFICATIONS:

• 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 manufacturing environments.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Light to Medium Heavy Work: Exerting up to 25 pounds of force constantly to move objects.
• Comfortably work while standing for long periods of time.
• Ability to perform tasks that may require reaching, bending, or positioning to access internal system components, with or without reasonable accommodation.

Cytek is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, gender identity, sexual orientation, national origin, genetic information, disability status, veteran status, or any other characteristic protected by law.