Consumable R&D Engineer

Key Responsibilities
Concept Engineering Translation & Product Design Lead the engineering translation of molecular diagnostics consumables (e.g., sample processing in DNA extraction and library preparation workflows) from product concepts, sketches, or functional requirements provided by the R&D team. Deliver complete design outputs from concept to physical product, including 3D modeling, structural design, material selection, tolerance analysis, and engineering drawing generation. Product Development & Iterative Validation Oversee and follow up on prototype fabrication and conduct systematic test validation of product physical performance, structural integrity, sealing, fluidic pathway integrity, and functional compliance. Drive design optimization and iteration based on test data, ensuring the consumable meets expected performance requirements within molecular diagnostics workflows. Process Development & Validation Lead or participate in the development of key manufacturing processes (e.g., injection molding, assembly, welding, bonding, tubing connections). Define process parameters and complete validation and verification of critical process steps. Collaborate with automation equipment teams or external suppliers to perform compatibility validation between consumables and automated workstations/liquid handling systems, ensuring dimensional fit, gripping/positioning alignment, pipetting/aspiration accuracy, and operational reliability in automated workflows. Automation Process Co-optimization Address the industry trend toward high-throughput and automated molecular diagnostics workflows by participating in joint testing of consumables with automated production lines/instruments. Optimize product structures to accommodate automated assembly, auto-feeding, auto-inspection, and other manufacturing processes, as well as end-user automation adaptability requirements. Technical Documentation & Regulatory Support Prepare technical documentation throughout the product development lifecycle (e.g., BOM, DHR, DFMEA, product specifications, process validation reports). Support compliance activities with relevant regulations and quality systems as required by the product's intended application. Cross-functional Collaboration & Production Scale-up Serve as the technical bridge between the Mainland engineering team and the Hong Kong R&D team, clearly communicating engineering implementation issues and automation validation findings. Upon product finalization, lead the smooth transfer of technical solutions and validated process parameters to the production department, assisting with SOP development and manufacturing introduction.

Qualifications:
• Master's degree or above in Polymer Materials Science & Engineering, Materials Processing, Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Automation, or a related STEM discipline.
• 5+ years of R&D/process development experience in medical devices, IVD or molecular diagnostics consumables, laboratory consumables, or similar high-precision polymer parts.
• Full product development experience (concept to mass production) preferred.
• Experience with molecular diagnostics consumables is a plus.
• Proficiency in at least one 3D CAD software, able to design complex plastics parts and product engineering drawings.
• Knowledge of polymer materials and processing techniques (injection molding, extrusion molding, etc.); capable of troubleshooting trial defects.
• Understanding of automation requirements (accuracy, alignment, gripping) for consumables; hands-on automation validation experience preferred.
• Familiarity with DFMEA, DOE, and other product development processes preferred.
• Regulatory Knowledge: Familiarity with ISO 13485 or ISO 9001 quality management systems; experience with Design Control is preferred.
• Strong cross-team communication skills, with the ability to report technical issues and progress clearly and structurally to the R&D team.
• Proficient in English with the ability to read English technical documents fluently, write technical reports, and handle written email communication in English.
• Strong analytical capabilities and systematic thinking, able to break down complex problems and propose solutions. Preferred Attributes:
• Familiarity with molecular diagnostics pre-analytical workflows and application scenarios.
• Experience collaborating with offshore/remote R&D teams.
• Familiarity with assembly processes for single-use consumables and automated assembly equipment.
• Experience in consumable-instrument integration testing or familiarity with automated production line validation protocols.
• Understanding of product registration or regulatory requirements (e.g., FDA 510(k), NMPA filing, CE-IVDR).

What We Offer
• Opportunity to participate in the complete 0-to-1 development of cutting-edge molecular diagnostics consumable products.
• A collaborative platform working closely with a high-caliber R&D team.