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Lead of the Instrument R&D team

China, Shanghai 600000.00 - 960000.00 CNY / Year · Job Posted March 11, 2026
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Job Description

As the core Lead of the Instrument R&D team, you will spearhead the system architecture design and full life-cycle development of high-end IVD equipment. Your focus will be on integrating hardware and software to solve complex engineering challenges while establishing a world-class R&D management system.

Job Responsibility

  • Lead the top-level design of high-end IVD instruments (e.g., Chemiluminescence, Flow Cytometry, Molecular Diagnostics)
  • define requirements and interfaces for optical, mechanical, electrical, fluidic, and software subsystems
  • Resolve critical bottlenecks in product development (e.g., anti-interference, temperature control precision, optical path alignment) while balancing performance, cost, and manufacturability (DFM)
  • Drive the entire process from project initiation, prototyping, and verification to New Product Introduction (NPI)
  • Ensure products meet NMPA/FDA/CE standards
  • oversee the output of high-quality Design History Files (DHF) and support registration/audit processes
  • Build and optimize R&D management processes (IPD) compliant with ISO and GMP standards, including risk management and design change control
  • Recruit, mentor, and manage a multidisciplinary team (Mechanical, Electronic, Software, Fluidics)
  • establish KPIs and talent development programs

Requirements

  • Bachelor’s degree or higher in Biomedical Engineering, Precision Instruments, Automation, Electronic Engineering, or related fields (Master’s/PhD preferred)
  • 5+ years of hands-on R&D experience in the medical device industry
  • Must have successfully led the development of at least one high-end IVD instrument (e.g., fully automated PCR or Chemiluminescence system) from concept to successful market launch (0 to 1)
  • A deep understanding of hardware circuits, low-level control logic, and high-level software architecture/algorithms
  • ability to bridge the gap between software and hardware teams
  • Proficient in fluid control, precision motion control, and optical detection principles
  • skilled in system error analysis and reliability design
  • Familiarity with medical device laws/regulations
  • experience in building R&D quality systems from scratch is highly preferred
  • Exceptional cross-functional communication, high pressure tolerance, an entrepreneurial spirit, and a strict result-oriented mindset

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