About the Company

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 Team

Joining 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.

About the Job

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.

Skills and Experience Required

• 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.

Please find more information here.