Medical Device Senior Technical Expert - Combination Products (m/f)

REFERENZNUMMER:

289123/11

IHRE AUFGABEN:

-Thorough project planning
-Lead the definition of product requirements for delivery systems, e.g. drug/device combination products and medical devices as well as the collaboration with external development partners
-Monitor work progress, development and implementation of manufacturing processes
-Monitor, support and challenge technical development as well as test and verification work
-Manage the collaboration with internal development partners and stakeholders
-Provide primary packaging and device expertise in a broader cross-functional drug product development team
-Support and coordinate the manufacturing of clinical material and the production scale-up
-Support cross-functional project teams in the development, review and submission of regulatory dossiers
-Manage and monitor Human Factors Engineering activities
-Plan and monitor design verification activities (in-house)

IHRE QUALIFIKATIONEN:

-Bachelor or Master degree in Science/Engineering or Mechanical Engineering or university-level Engineering education
-Excellent English language skills are required
-Excellent understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) is required
-Experience in design development of drug administration devices is required
-Experience in the development of syringes, auto-injectors or systems for drug delivery to critical areas is required

WEITERE QUALIFIKATIONEN:

R&D scientist