Medical Device Technical Expert (m/f)

REFERENZNUMMER:

329479/11

IHRE AUFGABEN:

-Generate Design Controls documentation while contributing to a high-quality Design History File (DHF) for parenteral delivery injection systems
-Author and Reviewer of DHF documents. Ensure quality and compliance to applicable regulations of the DHF elements of the assigned projects
-Ensure device design development in compliance with the regulations and delivered at a high quality
-Consult on the development of medical devices and combination products

IHRE QUALIFIKATIONEN:

-Profound experience in device development of parenteral delivery systems, e.g. drug/device combination products with main focus on medical devices for parenteral administration
-Experience in generating DHF documentation, including but not limited to design input requirements, technical specifications, design verification, design validation, and design transfer
-Excellent technical writing skills (e.g., Design Controls)
-Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) and of combination products (US)
-Experience in Product Design and Design for Manufacturing
-Good technical knowledge of primary containers development
-Good technical knowledge of auto injector development
-General understanding of Human Factors Engineering and Risk management

WEITERE QUALIFIKATIONEN:

Quality management employee