Senior Development Engineer

Germany  ‐ Vor Ort
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Schlagworte

Support Test Design

Beschreibung

We have an exciting opportunity of experienced design engineer to support development activities for medical devices type III.

Responsibilities:
further development of the technical file(s)
Manage verification planning and execution to achieve CE/FDA regulatory approvals, including management of external test laboratories
Identify technical needs and solutions to leverage scale up and international market access for products
Support development, verification and regulatory approvals (pre market approval) of a growing product portfolio in international markets
Requirements:
degree in a technical field of study, ideally with a mechanical focus
prior experience in R&D or QA role in the medical device industry
Proficient in state-of-the-art processes in medical device development (e.g. V-model, requirement engineering, risk management, test method validation)
Profound experience in verification testing of class III medical devices, ideally AIMD (active implantable medical devices) and/or implantable leads
Preferably experience in interactions with the FDA
Process-orientated, solution focused personality with can do attitude
Business fluent English

Please send your CV

Michael Bailey International is acting as an Employment Agency in relation to this vacancy.
Start
11/2020
Dauer
permanent
Von
Michael Bailey Associates
Eingestellt
07.11.2020
Projekt-ID:
1996021
Vertragsart
Festanstellung
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