Medical Device Verification Engineer / Technician (m/f)

REFERENZNUMMER:

282280/11

IHRE AUFGABEN:

-Evaluation, selection, design, development, characterization, industrialization of and interaction with medical devices for combination products (pre-filled syringe, needle safety device, auto injector, injector pen, infusion pump, new technology, special packaging)
-Practical evaluation of new and breakthrough technologies, development of new test methods
-Implementation and qualification/validation of new lab testing equipment
-Draw up of plans, protocols, reports as required in GMP facilities
-Organise test in the areas of experimental development, verification, complaint investigation and change evaluation
-Provide technical support to key customers in clinical and commercial phases (filling, packaging operations, regulatory, supply chain)
-Support the technology transfer of combination products and medical devices into commercial facilities/packaging centres (specification/method/equipment transfer)

IHRE QUALIFIKATIONEN:

-Technical education, preferably with an engineering degree
-Track record and experience in practical testing and characterisation of medical devices, special/innovative packaging
-Experience in working in the pharma industry under cGxP or similar working practices
-Sound knowledge regarding combination products and medical devices
-Demonstrable practical knowledge of the drug container integrity, parenteral drug delivery (sub-cutaneous, intra-venous, intra-muscular, transdermal)
-Basic experience in statistical techniques and risk assessment, instrument calibration, equipment qualification, functional testing and reliability, secondary packaging, transport studies and validation
-Excellent command of verbal/written German and English
-Excellent documentation skills under cGxP requirements
-Excellent team player
-Excellent IT knowledge (Zwick TestXpert II)

WEITERE QUALIFIKATIONEN:

Qualification/validation specialist