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Functional Safety Engineer Medizinprodukte

vor 4 Monaten

Rosenheim, Deutschland TÜV SÜD AG Vollzeit
AUFGABEN
  • Analyse und Bewertung der Sicherheitsarchitektur von Medizinprodukten
  • Erstellung von Prüfplänen zur Überprüfung der Erstfehlersicherheit auf Basis von Kundenanforderungen und Anforderungen aus anwendbaren Produktnormen
  • Eigenständige Prüfung der Funktionalen Sicherheit bzw. Softwaresicherheit bei aktiven medizinischen Geräten nach den relevanten Standards
  • Bewertung des Entwicklungslebenszyklus bei aktiven Medizinprodukten mit Software
  • Projekthandling und sorgfältige Betreuung unserer Kunden im In- und Ausland
  • Sicherstellung termingerechter Abarbeitung der Projekte
  • Erstellung von Berichten und Abschlussakten sowie Unterstützung bei der Neukundenakquise
QUALIFIKATIONEN
  • Erfolgreich abgeschlossenes technisches /naturwissenschaftliches Studium z. B. Elektrotechnik, Medizintechnik oder Physik
  • Mindestens 2 Jahr Berufserfahrung im technischen Bereich als Ingenieur in, wissenschaftliche r Angestellte*r oder in ähnlicher Beschäftigung
  • Kenntnisse der Normen IEC , IEC , sowie Erfahrung im Umgang mit QM-Systemen und Risikoanalysen wären wünschenswert
  • Erfahrung im Bereich Embedded Systems, Funktionale Sicherheit
  • Selbstständiges Arbeiten, korrekte und genaue Arbeitsweise sowie Empathie im Kontakt mit Kunden
  • Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift
  • Routinierter Umgang mit den MS Office-Anwendungen sowie mit C / C+ und/oder Java Grundkenntnisse
  • Reisebereitschaft ca. 20 % national/international (Pkw-Führerschein)