About the role
AI summarisedJoin the DxD Hub engineering team as a System Integration Engineer, serving as the technical expert responsible for coherently integrating subsystem design, assay science, and clinical application into functional prototypes and MVPs. You will drive the transformation of innovations into clinically validated diagnostic devices within an ISO 13485 compliant environment.
ResearchOnsiteDiagnostics Development Hub
Key Responsibilities
- Develop and maintain system-level architecture integrating mechanical, optical, electrical, firmware, and assay components into a functional device.
- Define and manage subsystem interfaces, integration strategies, and system-level verification activities across hardware, software, and chemistry domains.
- Co-manage project execution with the Project Manager by owning the technical workplan, tracking engineering milestones, and flagging risks.
- Translate scientific and clinical design inputs into engineering specifications, interface control documents, and integration test protocols.
- Lead or support design reviews, integration builds, and troubleshooting sessions during critical build phases.
- Author technical documentation including system specifications, integration protocols, and design history files compliant with ISO 13485.
- Coordinate across mechanical, optical, electrical, assay, and science teams to resolve integration conflicts.
- Support IP documentation by identifying novel system-level design concepts.
Requirements
- Bachelor's Degree or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or equivalent.
- 5–10 years in cross-functional product development experience.
- Proven experience completing at least one full development cycle from proof-of-concept to functional prototype or MVP.
- Hands-on experience integrating multi-domain subsystems.
- Demonstrated ability to hold both technical and coordination responsibilities concurrently in a project setting.
- Strong ability to decompose complex systems into subsystem interfaces and communicate integration logic clearly.
- Proficiency in at least one data analysis or instrumentation tool (e.g., Python, MATLAB, LabVIEW).
- Familiarity with ISO 13485 design control principles and documentation practices.