Senior System Designer – Sensing Lab

Job Title

System Designer – Sensing Lab

Job Description

In this role, you will have the opportunity to join the leading innovator in image-guided therapy solutions as System Engineer for Azurion Eye – Sensing Lab proposition. You will be responsible for defining and owning the system design for an integrated sensing, AI, and data analytics environment. You will translate clinical and business requirements into a coherent, scalable, and standards-compliant system design, spanning hardware interfaces, software subsystems, cloud connectivity, and data pipelines. You will act as system‑level technical authority, responsible for defining, owning, and evolving the end‑to‑end system architecture, behavior, and design across software, AI, data, and platform components that enable real‑time clinical workflow automation in a regulated medical environment.

You will be part of the Image Guided Therapy Systems (IGTS) business unit with development sites in the Netherlands, China and India. You will join the global R&D department working closely with cross-functional product development teams.

Key Areas of Responsibility

• Define and own the system-level architecture & design including hardware interfaces, AI subsystems, data pipelines, and cloud integration.

• Decompose top-level system requirements into subsystem and component-level specifications; maintain traceability from requirements to design and verification.

• Collaborate with AI Analytics, Data Analytics, and Infrastructure teams to ensure all subsystems integrate into a coherent and scalable platform.

• Lead architecture review boards; evaluate design alternatives and document trade-off analyses.

• Define and manage system interfaces between sensing hardware, embedded software, cloud services, and clinical dashboards.

• Identify and address non-functional requirements: performance, reliability, safety, cybersecurity, interoperability (DICOM, HL7), and regulatory compliance.

• Partner with Quality and Regulatory to ensure the system design adheres to IEC 62304, ISO 13485, and applicable medical device standards.

• Support verification and validation planning; define system-level test strategies and acceptance criteria.

• Engage clinical stakeholders to validate system design against real-world lab workflows and usability needs.

• Mentor engineers across teams on systems thinking, requirements engineering, and architecture best practices.

To Succeed in This Role, You Should Have the Following Skills and Experience

• Bachelor's or Master's degree (or PhD) in Systems Engineering, Electronics, Computer Science, Biomedical Engineering, or a related field.

• 10–15 years of experience in systems engineering for complex hardware/software products; experience in medical devices or health-tech strongly preferred.

• Proven expertise in system architecture definition, requirements engineering (e.g., SysML, UML), and interface management.

• Experience with medical device standards and regulatory frameworks (IEC 62304, ISO 13485, FDA 21 CFR Part 820).

• Familiarity with sensing technologies, camera/imaging systems, or clinical lab environments is a strong advantage.

• Knowledge of cloud architectures (AWS/Azure), microservices, and data pipeline design.

• Experience with DICOM, HL7, or other healthcare interoperability standards is advantageous.

• Strong systems thinking: ability to reason across hardware, software, data, and clinical workflow layers simultaneously.

• Experience with model-based systems engineering (MBSE) tools (e.g., Cameo, Rhapsody) is an advantage.

• Excellent written and verbal communication skills; ability to present complex architectures clearly to both technical and non-technical stakeholders.

• Proficiency in leveraging AI-assisted development tools to accelerate design, documentation, and analysis.