Medical Device Technical Expert (m/f)

REFERENZNUMMER:

338803/11

IHRE AUFGABEN:

-Run and lead technical development activities for medical devices e.g. Autoinjector, Safety syringes
-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
-Support DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions

IHRE QUALIFIKATIONEN:

-Experience in device development of parenteral delivery systems, e.g. drug/device combination products with main focus on medical devices for parenteral administration
-Experience 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 autoinjector development
-General understanding of Human Factors Engineering and Risk management
-General understanding of clinical trial processes and requirements
-General understanding of pharmaceutical development

WEITERE QUALIFIKATIONEN:

Project manager