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Principal Systems Architect - Instruments Cytek Biosciences Inc - 2.2 Bellevue, WA Job Details Full-time $176,000 - $220,000 a year 4 hours ago Qualifications Quality control corrective actions Developing medical devices Requirements specification Requirements design Coaching Contamination control Reliability analysis Corrective and preventive actions (CAPA) GMP System design for system development Design failure mode and effects analysis (DFMEA) Requirements analysis Design engineering Leading team collaboration initiatives Engineering product development Design controls Biomedical regulatory compliance Technical troubleshooting support Manufacturing Cross-functional team management Cross-functional communication FDA regulations Failure analysis Mechanical product development projects Full Job Description Cytek Biosciences is seeking an experienced Principal System Architect - Instrument to define and guide the architecture of next-generation flow cytometry platforms. This role is responsible for translating customer, application, and business needs into robust instrument designs, with particular focus on subsystem architecture, system reliability, and cross-functional execution with global teams and suppliers, including partners in China. This role is ideal for a professional who has worked with Class I, II, or III devices (including 510(k) cleared products) and thrives in environments undergoing cGMP and design control maturation.

Key Responsibilities:

Own the end-to-end system architecture for flow cytometry instruments, ensuring strong integration of fluidics, optics, electronics, software, and serviceability requirements. Define system requirements, interface specifications, and performance budgets to balance performance, reliability, manufacturability, cost, and scalability. Lead architecture decisions for fluidics subsystems, including sample handling, sheath flow, flow cell design, clog resistance, and contamination control. Drive reliability engineering activities, including failure mode analysis, reliability risk assessment, root cause analysis, corrective actions, and long-term robustness improvements. Establish and track system-level reliability goals such as uptime, MTBF, failure rates, maintenance intervals, and field performance metrics. Collaborate closely with R D, quality, manufacturing, service, and NPI teams to ensure design choices support product reliability and lifecycle performance. Work directly with internal teams and suppliers in China to align on technical requirements, resolve issues, support qualification, and drive on-time execution. Participate in supplier development, design reviews, risk mitigation, and technical issue resolution with global and China-based partners. Guidesubsystem teams through integration, verification, and validation activities, ensuring robust performance under real-world use conditions. Support design for manufacturability, serviceability, and supply chain resilience. Provide technical leadership and mentorship across engineering teams.

Qualifications:

Ph.D. or M.S. in Mechanical Engineering, Bioengineering, Physics, or related field. 8+ years of experience developing complex analytical, diagnostic, or life science instrumentation. Demonstrated experience in system architecture and cross-functional technical leadership. Strong understanding of fluidics systems, including flow control, microfluidics, particle transport, and contamination mitigation. Experience with reliability engineering methods such as FMEA, fault tree analysis, root cause analysis, and reliability growth. Strong troubleshooting skills and a bias toward root cause resolution and preventive action. Direct experience with Class I, II, or III medical devices, including 510(k) cleared products Experience operating in or helping build a cGMP-compliant environment Ability to translate customer and product needs into clear engineering requirements and trade-offs. Strong communicator who can teach, coach, and influence without formal authority Hands-on problem solver who enjoys working on the production floor as well as in documentation systems Ability to travel internationally (up to 20%) to support global manufacturing and cross-site collaboration

Preferred Experience:

Direct experience with flow cytometer, fluidic subsystems, or closely related technologies such as hematology analyzers, cell sorters, or microfluidic diagnostic systems. Experience in designing for high reliability, field performance, and serviceability in regulated instruments. Familiarity with optical detection systems, fluorescence, and signal acquisition. Professional workingproficiencyin MandarinChinese Hands-on experience coordinating with China- and APAC-based engineering and operations teams. Experience working with suppliers, contract manufacturers, or development partners in China. Experience in regulated environments such as ISO 13485 and FDA design controls. Proficiencywith modeling, simulation, or data analysis tools such as CFD, MATLAB, or Python.

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. Prolonged periods of sitting and standing 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. #LI-DNP