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.

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· 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).

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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.