IVD R&D Engineer

Dymind; Hong Kong; On-site; HKD 600,000 - 900,000; Full time

Job summary

Dymind Hong Kong subsidiary is expanding its R&D team to hire an IVD Reagent R&D Engineer. You will take end-to-end responsibility for reagent development, validation, and international registration documentation, while also managing daily lab operations in a GMP/ISO 13485 environment.

The role requires a Bachelor’s degree in biology/medicine/chemistry or related fields, with strong documentation skills and cross-functional collaboration.

Qualifications

• Bachelor’s degree or higher in biology, medicine, chemistry, or related fields.
• Degree from local HK university or joint local/non-local with recognition.
• Meticulous attitude, strong responsibility, and data documentation capability.
• Familiarity with ISO 13485 or GMP requirements.
• Knowledge of CE IVDR, FDA 510(k) regulations.

Responsibilities

• Develop end-to-end IVD reagent product development and validation.
• Draft and compile registration dossiers for international submissions (full-English).
• Manage daily laboratory operations, instrument maintenance, safety and compliant operation.

Skills

Documentation skills

Regulatory knowledge

Cross-functional teamwork

Lab management

Education

Bachelor’s degree or above

Biology/Medicine/Chemistry related disciplines

Job description

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.
• Familiar with ISO 13485 quality management system or GMP requirements.
• Knowledge of international regulatory requirements including CE IVDR, FDA 510(k).

What We Offer

Competitive remuneration package, comprehensive employee benefits, opportunity to participate in international IVD product development and registration projects, friendly collaborative team environment.