Device Development Engineer | Diagnostics Development Hub (DxD) | A*STAR

DxD Hub is Singapore's national platform for diagnostics development. With a mission to revolutionise diagnostics and improve healthcare outcomes, DxD Hub drives the transformation of innovations into clinically validated diagnostic devices ready for market adoption — leveraging an end-to-end, ISO 13485-compliant productisation engine across In Vitro Diagnostics, Point-Of-Care Connected Devices, Digital Diagnostics, and Digital Therapeutics. Our strengths are in cross-disciplinary product development particularly in molecular, protein assay, immunoassays, and digital diagnostic technologies.

Job Description

We are seeking a Prototype Development Engineer to join our Integrated Medical Technology engineering team. In this role, candidate will turn early-stage diagnostic concepts into engineered, testable prototypes — working across the full device stack from mechanical structure and biological elements integration and assay interface.

The preferred background is in mechanical engineering, with enough exposure to adjacent domains — biology, chemistry, electronics, or medical devices — to engage meaningfully across a multidisciplinary team. The work is hands-on and debugging a prototype at system level. Candidate will build deep expertise in translational device development while developing a good understanding in the clinical workflow. 

This role suits engineers with 5–10 years of experience who want to move beyond single-discipline work and develop into well-rounded device developers. 

Roles and Responsibilities

• Design, build, and iterate mechanical and biological components for diagnostic device prototypes, spanning 3D-printed, machined, and moulded parts across optical, electrochemical, LFA, PCR, and POCT platforms.
• Contribute to system-level prototype integration — assembling subsystems, resolving interface conflicts, and verifying that the assembled device behaves as the design intends.
• Plan and execute characterisation and prototype testing studies; design experiments, collect data, analyse results, and generate engineering reports that support design decisions.
• Develop and maintain test scripts in Python for data acquisition, instrument control, and test automation in support of verification activities.
• Support the translation of assay and clinical requirements into device design constraints, working closely with IVD scientists to understand what the device must do to the sample.
• Draft and execute test protocols in collaboration with the team, ensuring traceability, repeatability, and compliance with ISO 13485 design control requirements.
• Participate actively in design reviews, troubleshooting sessions, and cross-team discussions — contributing grounded, experimental observations rather than abstracted analysis.
• Create and maintain technical documentation including design records, fabrication drawings, test protocols, and reports.
• Manage your own task queue and communicate progress, blockers, and risks clearly to the team and project manager.

Key Requirement

• Bachelor’s degree or higher in Mechanical Engineering, Mechatronics, Biomedical Engineering, or a closely related discipline.
• 5–10 years of hands-on product or prototype development experience, including at least one project taken from early-stage concept to a functioning, testable prototype.
• Strong mechanical foundation: design for manufacture, tolerance thinking, material selection, and fabrication methods including 3D printing, machining, and moulding.
• Proficiency in 3D CAD (SolidWorks, Solid Edge, or equivalent) for part and assembly design.
• Proficiency in Python for data analysis and test automation; this is the primary scripting requirement for the role.
• Genuine curiosity about biology and diagnostic science — sufficient motivation to build working knowledge of assay principles, clinical workflows, and device-assay interactions on the job.
• Comfort operating with ambiguity: able to define a structured approach when requirements are incomplete and iterate rapidly when results do not match expectations.
• Strong documentation discipline and communication skills; able to write clearly and present experimental results to both engineering and non-engineering colleagues.
• Experience with or exposure to medical device development, ISO 13485, or a regulated product environment is an advantage.
• Familiarity with electronic prototyping, sensor interfacing, or firmware at a functional level — sufficient to collaborate with electrical engineers and contribute to system-level troubleshooting — is a meaningful advantage.
• Experience with simulation tools (FEA, CFD, or fluidic modelling) or optical/electrochemical characterisation methods is a plus