10.07.2025 aktualisiert
Senior Expert/Consultant Medical Devices
Skills
- Medical Devices and Development Processes:
Medical Device Regulation (MDR, regulation (EU) 217/745), ISO 13485, 21 CFR 820 (quality management), IEC 60601 series (medical electrical devices), IEC 62304 (medical software), ISO 14971 (risk management), IEC 62366 (usability), medical-device registration/certification processes (CE, FDA, NMPA), requirements management, verification & validation, configuration management, change management, systems engineering, system architecture - Project Management
- Product Management
- Team Management
- Technical Skills:
Radiation therapy and related techniques (dosimetry, imaging, patient positioning, control systems, treatment planning, ...), particle accelerators, accelerator physics, beamline magnets, superconductors, cryogenics
Sprachen
Projekthistorie
Company and team build-up support and PT system development activities for Schaer Proton as head of systems engineering and senior scientist
Major achievements:
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Adapted engineering processes to cover full particle therapy systems.
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Strongly affected set-up of RA/QM processes.
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Effected and strongly contributed to overall project task and resource planning.
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Effected and strongly contributed to hiring of engineering, RA and QM key resources.
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Introduced layout of overall system architecture.
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Introduced requirements tracing process and implemented according tools.
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Defined technical documentation structure.
Major achievements:
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Managed technical alignment between multi-national teams.
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Finalized major system design activities for new compact proton therapy system.
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Ensured compliance with medical-device standards and regulations.
Major achievements:
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Set up team of 10 multi-disciplinary system architects.
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Evaluated and introduced new system architecture concept and methods.