About the role
AI summarisedThe System Integration Engineer leads the technical convergence of mechanical, optical, electrical, and assay components for diagnostics development. This role focuses on bridging hardware engineering and clinical application to deliver functional IVD and POCT prototypes within an ISO 13485 framework.
ResearchOnsiteDiagnostics Development Hub
Key Responsibilities
- Develop and maintain system-level architecture that integrates 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, owning the technical workplan and tracking engineering milestones.
- Translate design inputs from scientific and clinical requirements into engineering specifications, interface control documents, and integration test protocols.
- Lead or support design reviews, integration builds, and troubleshooting sessions during critical build and verification phases.
- Author or oversee technical documentation including system specifications, integration protocols, test reports, and design history files in compliance with ISO 13485.
- Coordinate across mechanical, optical, electrical, assay, and science teams to resolve integration conflicts and maintain design coherence.
- Support IP documentation by identifying novel system-level design concepts and contributing to invention disclosures.
- Maintain awareness of competitive landscape and clinical workflows to evaluate design trade-offs at the system level.
Requirements
- Bachelor's Degree or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or equivalent.
- 5–10 years in cross-functional product development with at least one completed full development cycle from proof-of-concept to functional prototype or MVP.
- Hands-on experience integrating multi-domain subsystems with familiarity in at least two modalities such as optical detection, electrochemical sensing, microfluidics, LFA, PCR, or MEMS.
- Demonstrated ability to hold both technical and coordination responsibilities concurrently in a project setting.
- Strong ability to decompose complex systems into subsystem interfaces and generate system diagrams.
- Comfort operating in a research-adjacent environment where requirements evolve and technical paths are not always predefined.
- Proficiency in at least one data analysis or instrumentation tool (Claude Code, Python, MATLAB, LabVIEW, or equivalent).
- Familiarity with ISO 13485 design control principles and documentation practices.
- Experience with CAD or system modelling tools is advantageous; exposure to simulation tools (e.g., ANSYS, COMSOL) is a plus.
- Strong interpersonal and written communication skills with a proactive, curiosity-driven approach to problem-solving.