We are a high-tech pioneer in the life sciences and medical diagnostics sector, committed to localized innovation and the development of high-end, intelligent laboratory instruments. Backed by strong capital and cutting-edge R&D capabilities, we focus on breaking technical barriers in In-Vitro Diagnostics (IVD). Our mission is to provide global healthcare providers with more accurate, efficient, and reliable diagnostic tools through engineering excellence.
About the TeamJoining our team means stepping into a high-growth environment where your career trajectory is limited only by your ambition. As a core member of the leadership group, you will play a pivotal role in scaling the organization from its current phase to a dominant market player.
Scale and Support: We provide the substantial resources, capital, and cross-functional infrastructure necessary to bring complex products from concept to commercialization.
Career Path: This role is designed for a visionary leader looking to transition from "Senior Engineer" to "Strategic R&D Architect." You will have the autonomy to build your own team from the ground up, establish internal R&D cultures (IPD), and secure your position as a key executive in a rapidly expanding enterprise.
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.
System Architecture: 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.
Technical Decision-Making: Resolve critical bottlenecks in product development (e.g., anti-interference, temperature control precision, optical path alignment) while balancing performance, cost, and manufacturability (DFM).
Full Lifecycle Ownership: Drive the entire process from project initiation, prototyping, and verification to New Product Introduction (NPI).
Regulatory & Compliance: Ensure products meet NMPA/FDA/CE standards; oversee the output of high-quality Design History Files (DHF) and support registration/audit processes.
Framework Development: Build and optimize R&D management processes (IPD) compliant with ISO and GMP standards, including risk management and design change control.
Team Leadership: Recruit, mentor, and manage a multidisciplinary team (Mechanical, Electronic, Software, Fluidics); establish KPIs and talent development programs.
Educational Background: Bachelor’s degree or higher in Biomedical Engineering, Precision Instruments, Automation, Electronic Engineering, or related fields (Master’s/PhD preferred).
Industry Expertise: 5+ years of hands-on R&D experience in the medical device industry.
Proven Track Record: 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).
Systems Engineering Mastery: 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.
Technical Depth: Proficient in fluid control, precision motion control, and optical detection principles; skilled in system error analysis and reliability design.
Regulatory Fluency: Familiarity with medical device laws/regulations; experience in building R&D quality systems from scratch is highly preferred.
Soft Skills: Exceptional cross-functional communication, high pressure tolerance, an entrepreneurial spirit, and a strict result-oriented mindset.
