Sr. Systems Engineer
Cytek Biosciences Inc•Fremont, CA
•$126,000 - $185,000
About The Position
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.
Requirements
- Bachelor’s degree or higher in Systems Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Optical Engineering, Physics, Bioengineering, or a related technical field.
- 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.
Nice To Haves
- 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.
Responsibilities
- 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.
- 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.
- 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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
