Biomedical Systems Engineer — MBSE & Regulation

Hamilton Medical AG; Bonaduz; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

Hamilton Medical AG in Switzerland seeks a systems engineering professional to drive MBSE-driven product development for medical devices. You will derive system requirements, develop functional architecture, and ensure traceability from stakeholder needs through verification activities.

Collaborate with hardware, software, clinical and usability experts to advance regulatory compliance (MDR, ISO 13485/14971) and continuously improve engineering processes and toolchains.

Qualifikationen

• B.Sc. or M.Sc. in Engineering, Computer Science, Systems Engineering, or a related technical or scientific field.

Aufgaben

• Collaborate with cross-functional stakeholders to understand operational problems, stakeholder needs, assumptions, constraints, and workflows.
• 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 (e.g., 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 engineering processes, MBSE methods, and engineering toolchains.

Kenntnisse

Analytical mindset

Structured thinking

Systems thinking

Cross-functional collaboration

Ownership mindset

Effective communication

Ausbildung

B.Sc. or M.Sc. in Engineering, Computer Science, Systems Engineering, or a related technical or scientific field

Tools

Codebeamer

MBSE toolchains

ALM tools

Automation scripting

Jobbeschreibung

Hamilton Medical AG in Switzerland seeks a systems engineering professional to drive MBSE-driven product development for medical devices. You will derive system requirements, develop functional architecture, and ensure traceability from stakeholder needs through verification activities.

Collaborate with hardware, software, clinical and usability experts to advance regulatory compliance (MDR, ISO 13485/14971) and continuously improve engineering processes and toolchains.