Systems Engineer

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., 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., * 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.

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., * 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