09.03.2016 aktualisiert


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Physicist with medical/biomechanical experience
Waltenschwil, Schweiz
Deutschland
PhDSkills
21 CfrBerechnungenFmeaIec 62304Iso 13485ISO 14971ProjektmanagementProdukttestQualitätsmanagementRisikoanalyseTestpläne
- Quality assurance in accordance with the latest published European or international recommendations ( e.g. EN ISO 13485, EN ISO 14971, IEC 80002,EN IEC 62304 and GMP for Medical Devices -FDA 21 CFR 820).
- Risk analysis of clinical protocols, medical devices, software (FMEA).
- Testing (acceptance, commissioning, periodical) of medical devices in accordance with the latest published European or international recommendations.
- FEA and MB computer simulations and analysis of material models under different impact conditions.
- Internal and external project coordination
Sprachen
DeutschverhandlungssicherEnglischverhandlungssicherNiederländischgutPolnischMuttersprache