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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