IVD R&D Engineer

IVD Reagent R&D Engineer： About Dymind Biological Dymind is a fast‑growing in‑vitro diagnostic (IVD) enterprise, focusing on R&D, manufacturing and global marketing of medical diagnostic products. Our Hong Kong subsidiary is expanding the R&D team and we are now recruiting an IVD Reagent R&D Engineer to join us. Position Overview Based in Hong Kong subsidiary, the IVD Reagent R&D Engineer will take end‑to‑end responsibility for IVD reagent product development, validation, international registration documentation and laboratory daily management work, including performance evaluation, technical document compilation and lab compliance operation. Key Responsibilities - Develop performance evaluation protocols for IVD diagnostic kits; complete testing & verification on key performance indicators including sensitivity, specificity and stability; conduct statistical analysis on experimental data and compile research reports. - Draft and compile registration dossiers for IVD diagnostic kits, including product technical requirements, analytical performance study documents, stability study reports, product instructions and other technical files; capable of independently preparing full‑English registration technical documents for international submission. - Conduct daily laboratory management: instrument & equipment maintenance, lab consumables management, ensure laboratory safety and compliant operation. Requirements ✅ Must‑have - Bachelor’s degree or above. - Majors in Biology, Medicine, Chemistry and related disciplines: e.g. Biotechnology, Biochemistry & Molecular Biology, Immunology, Biomedical Science, Life Science, Medical Laboratory Science, Bioengineering, Pharmacy etc. - Degree qualification (meet one of the following): ‑ Degree awarded by a local Hong Kong university; ‑ Joint‑awarded degree from a local Hong Kong university and non‑Hong‑Kong university; ‑ Degree awarded by non‑Hong‑Kong universities ranked within TOP 100 of QS / ARWU / THE / US‑News world university rankings. - Meticulous working attitude, strong sense of responsibility; proven capability in technical documentation, data sorting and cross‑functional teamwork. ⭐ Preferred - Familiar with ISO 13485 quality management system or GMP requirements. - Excellent English reading & writing proficiency. - Knowledge of international regulatory requirements including CE IVDR, FDA 510(k). - Good Mandarin oral communication skills. What We Offer Competitive remuneration package, comprehensive employee benefits, opportunity to participate in international IVD product development and registration projects, friendly collaborative team environment.