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
Berufserfahrungmehr als 10 Jahre
Freelancer seit2021
DeutschMutterspracheEnglischverhandlungssicherFranzösischGrundkenntnisse
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.
Market monitoring, introduction of new product features, and research coordination for Varian Medical Systems as PT product manager
Major achievements:
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Implemented new product requirements and use cases.
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Conducted product review surveys with worldwide customers.
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Introduced new product features and development activities into product roadmap.
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Drove collaborative activities with research institutes.
Major achievements:
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Contributed significantly to winning of 4 new sales contracts.
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Actively participated in dialogue sessions with potential new customers.
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Introduced database for tender/RFP responses.
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Generated tender response documents.
Major achievements:
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Introduced new risk management process complying with updated normative requirements (EN 14971, EN 60601-1, 2nd and 3rd edition).
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Trained team in new process.
Major achievements:
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Implemented business line “Treatment Delivery Systems and Systems Engineering” and team (particle therapy)
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Updated proton therapy system design to enable a transition from a project approach to a product approach.
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Drove adaptation of Engineering processes and full update of proton therapy product and system requirements.
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Ensured compliance with medical-device standards and regulations.
Major achievements:
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Established overall work break-down structure and large fractions of project planning.
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Established system requirements.
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Established engineering processes.
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Significantly contributed to set-up of QA and regulatory environment and to generation and technical documentation for medical-device certification.
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Successfully drove development, fabrication, installation and commissioning of proton therapy subsystems (scanning system, gantries, patient tables, image guidance systems)
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Successfully conducted system verification and validation.
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Strongly contributed to sales activities.
Major achievements:
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Conducted tests enabling qualification of gantry (major proton therapy component) for shipment to customer site.
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Generated installation and commissioning plan.
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Significantly contributed to installation and commissioning activities.
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Performed design calculations for 2nd type of double-scattering nozzles (major proton therapy component).
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Contributed to RA/QM processes.
