Sr. Systems Engineer

Cytek Biosciences, Inc.; Fremont (CA); On-site; USD 90,000 - 125,000; Full time

Job summary

Cytek Biosciences, Inc. is seeking a Senior Systems Engineer in Fremont, CA, to support the development and lifecycle management of advanced flow cytometry instruments. This role involves collaborating with various engineering teams to ensure product performance and reliability.

The ideal candidate will have strong system-level thinking and over 5 years of experience in systems engineering. Responsibilities include leading requirement definition, system integration, and verification activities for cutting-edge medical devices.

Qualifications

• 5+ years of experience in systems engineering or integration of complex instruments.
• Experience working with multidisciplinary systems including hardware and software.
• Strong ability to define clear requirements and technical documentation.

Responsibilities

• Lead system-level requirement definition for flow cytometry instruments.
• Identify system-level risks early and drive mitigation plans.
• Support verification and validation activities for new product development.

Skills

System-level thinking

Technical problem-solving

Communication skills

Collaboration with cross-functional teams

Education

Bachelor’s degree or higher in relevant engineering field

Tools

Jama

Jira

MATLAB

Python

Job description

Cytek is seeking a Senior Systems Engineer to support the development, integration, verification, and lifecycle management of advanced flow cytometry instruments and related software/hardware systems. This role will work cross-functionally with R&D, software, firmware, hardware, optical, fluidics, assay, manufacturing, quality, regulatory, and service teams to translate product needs into system requirements, drive technical decisions, and ensure product performance, reliability, and usability.

The ideal candidate has strong system-level thinking, hands-on experience with complex electromechanical or optical instruments, and the ability to lead technical problem-solving across multiple engineering disciplines.

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.

System Design and Requirements

• Lead system‑level requirement definition, decomposition, and traceability for flow cytometry instruments and related products.
• Translate customer, clinical, manufacturing, service, and regulatory needs into clear and testable system requirements.
• Work with hardware, software, firmware, optics, fluidics, and assay teams to define interfaces, dependencies, and performance expectations.
• Support architecture decisions and trade‑off analysis for new product features and platform improvements.

Integration and Technical Leadership

• Lead system integration activities across instrument hardware, embedded firmware, application software, optics, fluidics, and reagents.
• Identify system‑level risks early and drive mitigation plans.
• Troubleshoot complex system issues involving signal quality, fluidics behavior, optical alignment, acquisition performance, QC behavior, and instrument reliability.
• Provide technical leadership during design reviews, issue investigations, and cross‑functional decision‑making.

Verification and Validation

• Develop and review system verification plans, test protocols, acceptance criteria, and reports.
• Support verification and validation activities for new product development, product updates, and sustaining engineering changes.
• Analyze test data, identify trends, and communicate conclusions clearly to technical and non-technical stakeholders.
• Ensure system‑level testing is aligned with product requirements, user needs, and regulatory expectations.

Product Quality and Lifecycle Support

• Support risk management activities, including hazard analysis, FMEA, and mitigation verification.
• Partner with Quality, Regulatory, Manufacturing, and Service teams to resolve field issues, manufacturing issues, and product performance concerns.
• Contribute to design changes, root cause investigations, CAPA support, and continuous product improvement.
• Help improve engineering processes related to requirements management, verification, system integration, and technical documentation.

REQUIREMENTS & QUALIFICATIONS

Required Qualifications

• Bachelor’s degree or higher in Systems Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Optical Engineering, Physics, Bioengineering, or a related technical field preferred.
• 5+ years of experience in systems engineering, product development, or integration of complex instruments.
• Experience working with multidisciplinary systems involving hardware, software, firmware, optics, fluidics, sensors, or biological assays.
• Strong ability to define clear requirements, test plans, acceptance criteria, and technical documentation.
• Experience with system verification, validation, root cause analysis, and data‑driven troubleshooting.
• Strong communication skills with the ability to work across engineering, quality, regulatory, manufacturing, service, and product teams.
• Ability to lead technical discussions, drive alignment, and make sound engineering judgments under ambiguity.

Preferred Qualifications

• Experience with flow cytometry, cell analysis, medical devices, diagnostics, life science instruments, or laboratory automation.
• Knowledge of fluorescence detection, lasers, PMTs/APDs, optical filters, signal processing, fluidics, or sample delivery systems.
• Experience with FDA-regulated or ISO 13485 product development environments.
• Familiarity with design controls, risk management, requirements traceability, verification/validation, and change control.
• Experience analyzing instrument performance metrics such as sensitivity, resolution, linearity, carryover, precision, event rate, QC performance, or signal‑to‑noise ratio.
• Experience using tools such as Jama, Jira, Confluence, Polarion, DOORS, JMP, MATLAB, Python, or similar data analysis and requirements management tools.

Key Competencies

• Strong system‑level thinking
• Requirements and verification discipline
• Cross‑functional leadership
• Hands‑on troubleshooting mindset
• Data‑driven problem solving
• Ability to manage ambiguity
• Clear technical communication
• Strong ownership and accountability

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.

• This role may involve office, laboratory, and engineering environments; frequent computer work; participation in cross‑functional meetings; and hands‑on interaction with complex flow cytometry instruments, related hardware, software, fluidics, optics, and laboratory equipment as needed.

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.