Manufacturing Engineer: Lean Process & Quality Improvement

Cytek Biosciences Inc

Fremont (CA)

On-site

USD 97,000 - 121,000

Full time

14 days+

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Job summary

Cytek Biosciences Inc in Fremont, CA is seeking a Manufacturing Engineer to optimize manufacturing processes and ensure high-quality production in a regulated medical device environment. This role focuses on solving mechanical, electrical, and optical issues, reducing downtime, leading Lean and Six Sigma projects, and driving process improvements to enhance throughput and product quality.

You will develop work instructions, validate equipment, and collaborate with design, quality, supply chain,

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.

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.