Location: Shenzhen Department: Research & Development / Reagents Engineering Reports to: R&D Manager / Head of Reagent Development Position Overview: We are looking for a talented Reagent Engineer to join our R&D team, responsible for developing and testing reagents used in hematology analyzers and other diagnostic devices. The successful candidate will work on formulating, validating, and optimizing reagents that meet the highest industry standards for clinical and diagnostic use. The Reagent Engineer will ensure that reagents are compatible with hardware and software systems to deliver accurate and reliable results. Key Responsibilities: · Reagent Development: o Formulate and develop reagents for hematology analyzers, focusing on consistency, accuracy, and reliability. o Conduct reagent testing and validation to ensure compatibility with medical diagnostic systems. o Work with cross-functional teams (software, hardware, and quality) to ensure that reagent formulations align with product specifications and regulatory requirements. · Quality Control & Testing: o Design and implement reagent testing protocols to evaluate their performance across different conditions (e.g., temperature, sample types). o Collaborate with the QA team to ensure that reagents meet medical device regulatory standards (e.g., ISO 13485, FDA). o Monitor reagent performance over time and make improvements to maintain or enhance quality and efficiency. · Collaboration: o Work closely with software engineers to ensure that reagent tests are integrated into the analyzer system, and results are accurately processed and reported. o Collaborate with manufacturing teams to scale up reagent production and ensure consistency and quality in large batches. o Provide technical support to the customer service and sales teams on reagent-related inquiries. · Regulatory Compliance: o Ensure all reagents comply with relevant health and safety regulations and standards. o Maintain thorough documentation on reagent formulations, batch records, and testing results for regulatory submissions. o Assist in regulatory filings and audits related to reagent products. · Innovation & Continuous Improvement: o Stay updated on advances in reagent technology and chemistry to continuously improve product offerings. o Troubleshoot and resolve any reagent-related issues in collaboration with other teams. o Optimize reagent formulations for cost-effectiveness and enhanced diagnostic capabilities. Qualifications: · Education: o Bachelor’s or Master’s degree in Chemical Engineering, Biochemistry, Biomedical Engineering, or a related field. o Additional certifications in reagent formulation or medical device development are a plus. · Experience: o Minimum of 5-8 years of experience in reagent development for medical devices or in-vitro diagnostics. o Experience working with hematology analyzers or other diagnostic systems is a plus. o Familiarity with reagent testing protocols and quality assurance practices. · Skills: o Strong knowledge of chemical formulation, biochemical assays, and reagent testing. o Familiarity with medical device regulations (e.g., FDA, ISO 13485). o Ability to work in a team environment and collaborate with cross-functional teams. o Strong analytical skills and attention to detail. · Other: o Experience in scaling up reagent production and working with manufacturers is a plus. o Strong understanding of the chemistry involved in blood analysis and hematology.