Systems Verification Engineer I

Cytek Biosciences; Fremont (CA); On-site; USD 75,000 - 100,000; Full time

Job summary

Cytek Biosciences in Fremont, CA is seeking a highly motivated, early-career engineer to join our cross‑functional team. You will participate in requirements definition, system integration, and verification/validation of multicolor flow cytometry instruments and assays.

Responsibilities include developing test methods, analyzing data to ensure compliance with product requirements, and contributing to risk management and design improvements.

Qualifications

• BS degree in Science, Engineering or Math field.
• 0–2 years in product development or verification for medical devices.
• Experience writing requirements and specifications.
• Knowledge across electrical, mechanical, optical, software and biomedical eng with troubleshooting.
• Familiarity with flow cytometry/hematology tech and Cytek products is a plus.
• Experience with Human Factors and Usability Engineering standards.
• Experience with System Engineering tools (e.g., Helix ALM, Jira, JMP, TestRail, DOORs).
• Excellent communication and presentation skills.

Responsibilities

• Supports product development and V&V of cell analyzers and sorters.
• Develops and executes test methods and protocols to verify requirements.
• Provides feedback on software workflows and instrument performance.
• Analyzes data to ensure compliance with product requirements.
• Develops requirements and specifications for new features.
• Assesses design feasibility and tests product functionality.
• Offers technical expertise and troubleshooting for flow cytometry instruments.
• Communicates issues and solutions with Systems and R&D teams.
• Uses user workflows knowledge to drive product improvements.

Skills

Verbal and written communication

Root cause analysis

Cross-functional collaboration

Documentation

Presentation skills

Education

BS in Science/Engineering/Math

Tools

Helix ALM

Jira

JMP

TestRail

DOORs

Job description

Cytek Biosciences is pioneering next‑generation tools in flow cytometry and cell analysis. Through our Full Spectrum Profiling™ technology and integrated reagent/application platforms, we empower scientists to push the boundaries in immunology, oncology, cell therapy, and basic biology. We believe that blending precision instrumentation with thoughtfully designed reagents and applications is the path to enabling the most advanced experiments—faster, easier, and more informative.

We are seeking a highly motivated candidate who can work with cross‑functional teams to conduct requirements definition, system integration, characterization, verification/validation, and risk management in the design, execution, analysis and troubleshooting of multicolor flow cytometry instruments and assays.

Essential Duties And Responsibilities

• Supports technical product development, verification and validation (V&V) of cell analyzers and sorters.
• Develops and executes test methods and protocols to ensure requirements are successfully tested and met.
• Provide feedback, both verbal and written on software workflows and instrument performance for iterative product development.
• Conducts analysis and interpretation of data to ensure compliance with product requirements.
• Develops requirements and specifications.
• Assess design feasibility and test product functionality.
• Provide technical expertise and troubleshooting for complex flow cytometry instruments.
• Communicate effectively with both the Systems and R&D groups to describe issues and understand solutions.
• Use knowledge of common user workflows to drive product improvements.

Requirements & Qualifications

• BS degree in Science, Engineering or Math discipline.
• 0-2 years of experience in product development and/or verification for medical devices/in vitro diagnostics systems or similar.
• Experience in writing requirements and specifications.
• General knowledge across electrical, mechanical, optical, software, and biomedical engineering and associated root cause analysis/troubleshooting skills.
• Experience and knowledge of flow cytometry and/or hematology technology and products.
• Familiarity with Human Factors and Usability Engineering standards.
• Experience in System Engineering tools (e.g. Helix ALM, Jira, JMP, TestRail, DOORs).
• Excellent communication and presentation skills.

Desired Qualifications

• Strong knowledge of flow cytometry principles.
• Experience with risk management.
• Experience with design transfer activities.
• Experience with Cytek products and SpectroFlo software.

Physical Demands And Work Environment

• Some tasks require an employee to work in an environment that involves some risk of sustaining illness and injury from the use of biological materials (human blood or cells) and high energy light sources (lasers) and voltage.
• Ability to lift 50 lbs.

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.