Medical Device Technical Expert (m/f)

REFERENZNUMMER:

302275/11

IHRE AUFGABEN:

-Compile Design Control documentation and contribute to a high quality Design History file
-Plan and lead technical activities
-Manage technical development activities in collaboration with internal development partners
-Lead the collaboration with external development partners
-Monitor work progress according to plan
-Monitor, support and challenge technical development as well as test and verification work
-Monitor development and implementation of manufacturing processes
-Coordinate and monitor technical documentation
-Lead or participate in risk management activities
-Support Human Factors Engineering activities

IHRE QUALIFIKATIONEN:

-Master degree in Science/Engineering or Mechanical Engineering or University level Engineering education
-Experience in pre-filled-syringe device development is beneficial
-Experience in intravitreal drug delivery, medical devices for ophthalmic applications
-Experience in DHF compilation
-Understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive)
-Experience in product design/Design for manufacture
-Good communication and conflict solving skills
-Excellent English language

skills

WEITERE QUALIFIKATIONEN:

Medical affairs manager