Systems Verification Engineer I

Cytek Biosciences, Inc.; Fremont (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Cytek Biosciences is seeking a candidate to join cross-functional teams in defining requirements, integrating systems, and validating multicolor flow cytometry instruments and assays. You will contribute to verification/validation, test method development, and troubleshooting across electrical, mechanical, optical, software, and biomedical domains.

The role emphasizes translating user workflows into product improvements and requires strong communication and problem-solving skills for

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.

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.

Skills

Product development

Verification

Requirements writing

Root cause analysis

Flow cytometry

Hematology tech

Human Factors

Usability Engineering

System engineering tools

Communication skills

Education

BS degree in Science, Engineering or Math

Tools

Helix ALM

Jira

JMP

TestRail

DOORs

Job description

Cytek Biosciences is pioneering nextgeneration 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

To perform this job successfully, an individual must be able to perform essential duties and responsibilities satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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

The requirements listed below are representative of the knowledge, skill, and/or ability required.

• 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

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

• 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.