Lead Molecular Diagnostics Consumables R&D Engineer

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

Job summary

Insighta Limited in Hong Kong seeks a Concept Engineering Translation & Product Design lead to drive the engineering translation of molecular diagnostics consumables from concept to physical product. You will deliver design outputs, including 3D modeling, drawings, and material selection, coordinating with R&D to ensure manufacturability.

You will oversee prototype validation, process development for injection molding and assembly, and ensure regulatory clarity with ISO frameworks while bridging

Qualifications

• Master's degree or above in a STEM field relevant to polymer materials and engineering.
• 5+ years of R&D/process development experience in medical devices, IVD, or molecular diagnostics consumables.
• Full product development experience from concept to mass production.
• Proficiency in at least one 3D CAD software for plastics parts and drawings.
• Knowledge of polymer materials and processing (injection/extrusion molding) and ability to troubleshoot defects.
• Understanding of automation requirements for consumables, with hands-on validation experience preferred.
• Familiarity with DFMEA, DOE, and other product development processes.
• Regulatory knowledge: familiarity with ISO 13485 or ISO 9001; Design Control preferred.
• Strong cross-team communication to report issues and progress.
• Proficient English reading/writing for technical documents and emails.
• Strong analytical capabilities and systematic problem solving.

Responsibilities

• Lead translation of product concepts into manufacturable designs and drawings.
• Oversee prototype fabrication and validation of product performance and integrity.
• Develop and validate manufacturing processes (e.g., injection molding, assembly, bonding).
• Coordinate with automation teams and suppliers for compatibility validation.
• Collaborate on process optimization for high-throughput automated workflows.
• Prepare technical documentation (BOM, DHR, DFMEA, specs).
• Bridge Mainland engineering with Hong Kong R&D and support production transfer.

Skills

Cross-functional collaboration

Analytical thinking

Excellent English communication

Education

Master's degree or above in Polymer Materials Science & Engineering, Materials Processing, Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Automation, or related STEM

Tools

3D CAD software

Job description

Insighta Limited in Hong Kong seeks a Concept Engineering Translation & Product Design lead to drive the engineering translation of molecular diagnostics consumables from concept to physical product. You will deliver design outputs, including 3D modeling, drawings, and material selection, coordinating with R&D to ensure manufacturability.

You will oversee prototype validation, process development for injection molding and assembly, and ensure regulatory clarity with ISO frameworks while bridging