Systems Engineer - Medical Devices & MBSE Expert

Job-Room; Bonaduz; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Hamilton Medical is seeking an experienced MBSE/Systems Engineer in Switzerland to shape next-generation ventilator systems. You will collaborate across software, hardware, and clinical teams to develop architecture, manage requirements, and ensure traceability, quality, and regulatory compliance.

The role emphasizes cross-disciplinary problem solving, MBSE toolchains, automation, and continuous improvement of engineering processes in a regulated medical device environment.

Qualifikationen

• Degree in Engineering, Computer Science, Systems Engineering, or a related technical field.
• Experience in medical device development or regulated industry is preferred.
• Knowledge of MBSE methods and traceability across system architecture and verification.

Aufgaben

• Collaborate with cross-functional stakeholders to understand operational problems, stakeholder needs, assumptions, constraints, and workflows, contributing to a shared understanding of the product's intended use and value.
• Derive and manage system requirements and support the development of the functional architecture, ensuring traceability between stakeholder needs, system behavior, and verification activities.
• Contribute to the development of the physical architecture by working with software, hardware, mechanical, clinical, and usability experts to evaluate and realize technical solutions.
• Plan and support integration, verification, and validation activities, and contribute to regulatory compliance (MDR, FDA, ISO 14971) through risk management, reliability analysis, documentation, and evidence generation.
• Promote effective communication, collaboration, and systems thinking across disciplines while supporting the continuous improvement of MBSE processes, engineering toolchains, and lifecycle management.

Kenntnisse

MBSE

Systems Eng

Requirements Eng

Architecture Dev

Traceability

Regulatory Compliance

MBSE Toolchains

Codebeamer

Automation/Scripting

Regulatory Standards

Tools

Codebeamer

Jobbeschreibung

Hamilton Medical is seeking an experienced MBSE/Systems Engineer in Switzerland to shape next-generation ventilator systems. You will collaborate across software, hardware, and clinical teams to develop architecture, manage requirements, and ensure traceability, quality, and regulatory compliance.

The role emphasizes cross-disciplinary problem solving, MBSE toolchains, automation, and continuous improvement of engineering processes in a regulated medical device environment.