Consumable R&D Engineer (Molecular Diagnostics Consumables)

Insighta Limited; Hong Kong; Presencial; HKD 600.000 - 900.000; Jornada completa

Descripción de la vacante

Insighta Limited in Hong Kong is seeking a senior engineer to lead concept-to-product development of molecular diagnostics consumables, including 3D modeling, material selection, and tolerances. You will ensure design outputs meet performance and regulatory expectations.

You will oversee prototype fabrication, validate physical performance, and drive process development for injection molding, assembly, and automation.

Formación

• Master's degree or higher in a STEM field.
• 5+ years of R&D or process development in medical devices or molecular diagnostics.
• Experience from concept to mass production preferred.

Responsabilidades

• Lead translation from concept to physical product with 3D modeling and drawings.
• Validate prototypes and drive design optimization from test data.
• Develop manufacturing processes and validate critical steps.
• Collaborate with automation teams and suppliers on compatibility.
• Prepare technical documentation and support regulatory activities.
• Coordinate cross-functional transfer to production and SOPs.
• Communicate findings clearly to R&D teams.

Conocimientos

Polymer materials science

Mechanical engineering

Automation

3D CAD

DFMEA/DOE

Quality/regulatory knowledge

Cross-functional collaboration

Problem solving

English technical writing

Educación

Master's degree or above in STEM

Herramientas

3D CAD

Descripción del empleo

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.