System Engineer 80 - 100 % (w/m/d)

Hamilton Medical; Bonaduz; Vor Ort; CHF 110.000 - 170.000; Vollzeit

Zusammenfassung

Hamilton Medical, a leader in intelligent ventilation, seeks an experienced systems engineer to shape the next generation of medical devices. You will work across software, hardware, and clinical teams to define system requirements, architecture, and verification strategies in a regulated environment.

You bring MBSE expertise, strong communication across disciplines, and a proactive mindset. English fluency is required; German is a plus.

Qualifikationen

• Experience in medical device development or regulated industries.
• Strong systems thinking and problem solving.
• Knowledge of MDR, FDA, ISO 13485 and ISO 14971 is a plus.

Aufgaben

• Derive and manage system requirements and support architecture development.
• Coordinate across software, hardware, clinical, and usability teams.
• Support formal verification, validation, and regulatory documentation.

Kenntnisse

MBSE

Requirements engineering

Systems engineering

Traceability

Regulated industry

Stakeholder management

English fluent

Ausbildung

B.Sc./M.Sc. in Engineering

Tools

Codebeamer

MBSE toolchains

Jobbeschreibung

For more than 40 years, Hamilton Medical has shaped the future of mechanical ventilation. We develop Intelligent Ventilation solutions that support clinicians in critical moments. Our Hamilton ventilators are used in intensive care units, during emergency transport, and in MRI environments. They help medical teams care for adult, pediatric, and neonatal patients worldwide. Here, your work has real impact. Every improvement you make supports better respiratory care for patients around the globe.

How you can make a difference:

• 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 (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.

That’s what you bring along:

• B.Sc. or M.Sc. in Engineering, Computer Science, Systems Engineering, or a related technical or scientific field.
• Experience in medical device development or another regulated industry, with a good understanding of product development processes and lifecycle activities.
• Knowledge of systems engineering, requirements engineering, architecture development, and traceability. Experience with MBSE methods and tools is an advantage.
• Knowledge of relevant regulations and standards (e.g., MDR, FDA, ISO 13485, ISO 14971, IEC 60601-1) and their application within product development.
• Strong analytical, structured, and systems-thinking mindset with the ability to solve complex technical problems.
• Strong communication, collaboration, and stakeholder management skills, with the ability to work effectively across disciplines and organizational boundaries.
• Experience with ALM, requirements, and engineering lifecycle management tools (e.g., Codebeamer) is beneficial. Experience with MBSE toolchains, automation, scripting, or tool integration is an advantage.
• Interest in MBSE, digital engineering, AI-assisted workflows, and continuous improvement of engineering methods and processes.
• Proactive, solution-oriented, and resilient team player with a strong sense of ownership and a passion for technical excellence.
• Fluent in English; German language skills are an advantage.