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Open nowPosted 117 days ago

Systems & Requirements Engineer (w/m/d) – Medizintechnik

getec-holding38 open roles

Where
Magdeburg
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Your applicationOpen nowSystems & Requirements Engineer (w/m/d) – Medizintechnikgetec-holding · Magdeburg

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The clock on this job

Early applications get read.

8.0% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 1.6%1 day
  2. 3.6%3 days
  3. 8.0%7 days
  4. 15.0%14 days
  5. 34.2%30 days
This job: posted 117 days ago

The posting

Aufgaben

  • Du erhebst, analysierst und strukturierst System-/Produktanforderungen (Workshops, Use Cases/User Stories) und formulierst klare, testbare Spezifikationen.
  • Du übersetzt regulatorische Anforderungen (u. a. MDR, ISO 13485, IEC 62304, EN 60601, ISO 14971) in konsistente Design Inputs.
  • Du verantwortest das Requirements Lifecycle Management (Versionierung, Baselining, Change Control & Impact Analysis).
  • Du sicherst End-to-End-Traceability zwischen Anforderungen, Design/Architektur, Risiken und Verifikation/Validierung.
  • Du gestaltest Risikomanagement nach ISO 14971 aktiv mit (Hazards, Bewertung & Maßnahmen).
  • Du moderierst Zielkonflikte & Prioritäten (Trade-offs) und wirkst an skalierbaren Prozessen/Tools (z. B. V‑Modell, Requirements-/Traceability-Tooling) mit.

Profil

  • über 5 Jahe Erfahrung im Systems Engineering / Requirements Engineering, idealerweise MedTech (oder vergleichbar reguliertes Umfeld).
  • Erfahrung mit komplexen Systemen aus Hardware und Software.
  • Erfahrung im Requirements Management inkl. Traceability und Change Control; Anforderungen präzise und testbar formulieren.
  • Sicherer Umgang mit relevanten Normen und Standards (ISO 13485, IEC 62304, ISO 14971, DIN EN 60601-Reihe).
  • Vorteilhaft: Erfahrung mit Tools wie DOORS, Polarion, Jama (oder vergleichbar) sowie Prozess-/QMS-Weiterentwicklung.
  • Du arbeitest strukturiert, eigenverantwortlich, mit hohem Qualitätsanspruch.
  • Sehr gute Deutsch- und gute Englischkenntnisse in Wort und Schrift.

Unser Angebot

  • Innovationsträger: die Möglichkeit, ein weltweit einzigartiges MedTech-Produkt entscheidend mitzugestalten
  • Zentrale Rolle: direkter Einfluss auf Produktstruktur, Qualität und Zulassungsfähigkeit
  • Gestaltungsspielraum: aktive Mitwirkung beim Aufbau von Prozessen, Methoden und Toollandschaften
  • Professionelles Umfeld: ein interdisziplinäres, hochqualifiziertes Team mit kurzen Entscheidungswegen
  • Entwicklung: langfristige Perspektive und die Chance, fachlich wie organisatorisch mit dem Unternehmen zu wachsen

Recruiting

RAYDIAX ist ein aufstrebendes MedTech-Unternehmen aus Magdeburg. Wir entwickeln den weltweit ersten Therapie-Assistenz-CT und bereiten derzeit die internationale Markteinführung vor. Unser Ziel ist es, mit unserer Technologie neue Standards in der minimalinvasiven Medizin zu setzen. Mit unserem starken interdisziplinären Entwicklungsteam haben wir die technische Basis geschaffen – nun geht es darum, unsere Produktentwicklung strukturiert, normkonform und skalierbar weiterzuentwickeln. Dafür suchen wir einen erfahrenen Systems & Requirements Engineer (w/m/d), der regulatorische Anforderungen, Systemverständnis und Engineering-Praxis zusammenbringt.

Kontakt: Team Recruiting Tel.: +49 511 121088 -642

Wir freuen uns auf deine Bewerbung, auch wenn du nicht jeden Punkt zu 100% erfüllst!

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