Location: Shenzhen Department: Research & Development / Software Engineering Reports to: R&D Manager / Head of Software Development Position Overview: We are seeking a highly skilled Software Engineer to join our Research & Development team. The successful candidate will be responsible for developing, testing, and maintaining software for hematology analyzers and other medical devices. The ideal candidate will work closely with cross-functional teams to design and implement software solutions that meet regulatory standards and deliver high-accuracy results in diagnostics. Key Responsibilities: · Software Development: o Develop software for hematology analyzers (e.g., Mindray BC-5300) focusing on blood analysis algorithms, system integration, and hardware interfacing. o Write clean, maintainable, and efficient code for embedded and application-level software. o Develop algorithms for key features like 5-part WBC differential, scattergrams, and other diagnostic functionalities. o Implement software updates, patches, and enhancements as required. o Oversee the design, development, and optimization of software for Hematology Analyzers, including algorithms and user interfaces supporting 5-Part WBC Differential analysis (neutrophils, lymphocytes, monocytes, eosinophils, basophils) and 3D Scattergram generation. · Technical Expertise: Leverage expertise in signal processing, data visualization, and real-time analytics to enhance scattergram accuracy and the differentiation of blood cell populations using technologies like tri-angle laser scatter, flow cytometry, and chemical dye methods. o · Testing & Validation: o Design and conduct software testing protocols to ensure the functionality and reliability of the product. o Collaborate with the QA team to ensure compliance with medical device regulations (e.g., FDA, ISO 13485). o Perform debugging, troubleshooting, and performance tuning of software systems. · Collaboration: o Work closely with hardware engineers to ensure seamless software-hardware integration. o Collaborate with reagent scientists to ensure software compatibility with reagent-based tests. o Participate in product development meetings to align software features with the overall product roadmap. · Documentation: o Maintain detailed and accurate documentation of software specifications, design, and test results. o Prepare software release notes and user manuals for internal and external use. o Ensure software development processes comply with regulatory standards. · Continuous Improvement: o Stay up-to-date with industry trends and technologies to propose innovative solutions for software development. o Optimize existing software systems to improve performance, scalability, and user experience. Qualifications: · Education: o Bachelor’s or Master’s degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field. o Additional certifications or courses in medical device software development are a plus. · Experience: o Minimum of 5-8 years of experience in software development, with a focus on medical devices or in-vitro diagnostics. o Experience with embedded software development and algorithm programming. o Familiarity with medical device regulations (e.g., FDA, CE Mark, ISO 13485) and software validation processes. · Skills: o Strong knowledge of C/C++, Python, or other relevant programming languages. o Experience with embedded systems and real-time operating systems (RTOS). o Familiarity with algorithm development for diagnostic purposes. o Experience with signal processing, data visualization, or machine learning for scattergram analysis and cell differentiation. o Knowledge of software integration with hardware sensors (e.g., laser scatter, flow cytometry). o Understanding of database systems and communication protocols (e.g., HL7, TCP/IP). o o Ability to collaborate in cross-functional teams and communicate technical details effectively. o Strong problem-solving skills and attention to detail. · Other: o Experience with hematology analyzer software is highly desirable. o Strong understanding of software testing tools, methodologies, and debugging practices.