Device Development Engineer (m/f)

REFERENZNUMMER:

315548/11

IHRE AUFGABEN:

-Development and support for medical devices and a drug delivery devices combination product portfolio
-Apply scientific approach to run design of experiments
-Perform risk analysis as part of the device development
-Provide high quality input and documentation for interaction with regulatory authorities
-Work according to quality management systems such as ISO 13485 and 21CFR820, risk management according to ISO 14971, design control, compilation of Design History File

IHRE QUALIFIKATIONEN:

-Experience in primary packaging development
-Profound experience in a technical engineering discipline (mechanical engineering preferred)
-Sound analytical and leadership skills and a capability to identify and develop new technology opportunities
-Demonstrable knowledge of parenteral drug containers and delivery (including devices such as pre-filled syringes, auto-injectors, needle safety devices etc.)
-Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices

WEITERE QUALIFIKATIONEN:

Quality manager