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System Engineer
Job in
7402, Bonaduz, Kanton Graubünden, Switzerland
Listed on 2026-07-02
Listing for:
Hamilton Medical AG
Full Time
position Listed on 2026-07-02
Job specializations:
-
Business
Regulatory Compliance Specialist
Job Description & How to Apply Below
Location: Bonaduz
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- Transfer and restructuring of existing technical documentation into Codebeamer, ensuring consistency, traceability and compliance with regulatory requirements
- Setup, structuring and continuous improvement of the system architecture, requirements structure and data model in Codebeamer to support the full product lifecycle (development, verification, changes)
- Ensure traceability between requirements, risks, verification and design documents (e.g. architecture, specifications and interfaces) within Codebeamer
- Contribute to regulatory compliance (e.g. MDR, FDA,ISO 14971) by supporting risk management, verification and documentation activities
- Collaborate with cross‑functional teams (R&D, RA, Change Management, etc.) to align system architecture and documentation
- Provide transparent progress updates and proactively drive improvements in system engineering processes and tooling
- B.Sc. or M.Sc. in engineering or a related scientific field (ETH, university, or equivalent)
- Prior experience in the field of medical product development is beneficial
- Experience with Codebeamer is beneficial
- Solid understanding of regulatory requirements (ISO 13485, FDA, MDR) and the processes for developing medical products is beneficial
- Strong analytical and systematic problem‑solving skills
- Strong communication skills to coordinate and motivate teams (interface management)
- Mindset for continuous improvement, actively initiating topics and getting involved in ongoing activities
- Fluent English with the ability to speak German (min. B2 level)
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