Manufacturing Engineer

Cytek Biosciences; Fremont (CA); On-site; USD 75,000 - 95,000; Full time

Job summary

Cytek Biosciences, based in Fremont, CA, seeks a Manufacturing Engineer to lead high-impact projects in production. The individual will troubleshoot complex mechanical, electrical, and optical issues, drive continuous improvements, and support new product introductions.

Candidates should have a BS Degree in Mechanical or Industrial Engineering and a minimum of 3 years in system integration/testing. Six Sigma certification is preferred, alongside strong communication skills and experience in a medical device manufacturing environment.

Qualifications

• Minimum 3 years experience supporting system integration/testing.
• Understanding of ISO13485 is desired.
• Knowledge of PCBA, Lasers, optics, and fluidic systems is a plus.

Responsibilities

• Lead troubleshooting of optics, fluidics, and equipment in production.
• Identify and resolve production process issues.
• Document field failure investigations and root causes.

Skills

Six Sigma certification (greenbelt or blackbelt)

Good written and verbal communication skills

Statistical Expertise

Proficiency in Design of Experiment statistics

Experience with Medical Device Manufacturing

Education

BS Degree in Mechanical or Industrial Engineering

Tools

Statistical software

Job description

The Manufacturing Engineer (ME) will be expected to lead parallel high impact projects and helps with continuous and uninterrupted flow of the production process. The ME is expected to contribute new ideas and find innovative methods to accomplish production goals. Works on complex mechanical, electrical, and optical problems where analysis of situations or data requires an in-depth evaluation of various factors. The ME will be responsible of solving production issues quickly and reducing downtime using a data driven approach.

Essential Duties And Responsibilities

• Directs personnel in the troubleshooting of Optics, fluidics and equipment components used in Integration, subassembly, and final test process.
• Take lead in identifying problems and pursuing plans toward their resolution to improve quality, waste, and equipment efficiency in production process.
• Ability to handle projects of a moderate to large scope requiring extensive cross functional coordination. Will be required to handle several assignments (project & process duties) simultaneously.
• As required within the scope of their duty, be responsible for all associated documentation, including however not limited to, the following validations, Operations Procedures, Preventive Maintenance schedules, Engineering Change Notifications, spare parts listings, etc.
• Provide adequate support of the introduction of new products into manufacturing while supporting the production of existing products.
• Perform and document field failure investigations, identify root causes, reduce process scrap, and participate in corrective and preventive action efforts.
• Lead continuous improvement projects to support cost reduction, on-time delivery, customer complaints and production capacity goals.
• Perform other related duties and assignments as required and ability to read and interpret drawings and schematics.
• Responsible for improving the product quality by Investigating root causes, design and implementing fail proof (poke yoke) solutions.
• Analyze in-process and analytical data, draw sound conclusions, and provide recommendations related to process improvement activities.
• Work very closely with production staff to reduce instrument down time and increase output by performing documented training and coaching.
• Must be adept in resolving and determining root cause of technical mechanical, optical, and electrical issues encountered in Production during Assembly and Test.
• Collaborate cross-functionally with development, supply chain and production teams to deliver product and process solutions and improvements that achieve company objectives.
• Responsible for reducing labor hours/unit, manufacturing lead time and failure at installation.
• Responsible for material transaction and keeping an accurate inventory in the manufacturing production floor.

Requirements & Qualifications

• Six Sigma certification (greenbelt or blackbelt) preferred.
• BS Degree in Mechanical or Industrial Engineering with minimum3yearsexperiencesupporting system integration/ testing or equivalent.
• Understanding ISO13485 is desired.
• Familiarity with Medical Device Manufacturing environment is desired.
• Knowledge of PCBA, Lasers, optics and fluidic systems is a plus.
• Must possess good written and verbal communication skills, and be able to adapt quickly to changes, prioritize and execute multiple tasks in the fast-paced environment.
• Statistical Expertise: Proficiency in applying Design of Experiment statistical approaches during process optimization and scale-up.
• Familiarity with statistical software for data analysis.
• Experimental Design: Proven experience in designing and executing experiments, drawing meaningful conclusions, and providing recommendations based on experimental data.

Physical Demands And Work Environment

• Light to Medium Heavy Work: Exerting up to 25pounds 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.