Device Test Engineer (m/f)

- Practical evaluation, characterization and verification of medical devices for combination products (e.g., pre-filled syringe, needle safety device, autoinjector, 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
- Generation of plans, protocols, reports as required
- Perform experimental, development, Verification, complaint investigation and change evaluation testing
- Liaison with; and provide technical support to; key customers in clinical and commercial phases - such as filling, assembly and packaging
- operations, packaging and quality groups, regulatory, process and formulation development groups, supply chain
- Support to Technology Transfer of combination products and medical devices into commercial facilities/packaging centers
- Technical education, preferably with an engineering degree
- Experience in track record and experience in practical testing and characterization of medical device, special/innovative packaging, or in development sector specializing in compact, complex, multi-material hand-held products
- Ideally experienced in 3D measurement techniques
- Experience of working in pharma or other closely-regulated environment, under cGxP, QSR or similar working practices
- Sound knowledge of legislation, regulation, industry standards and guidance around the area of combination products and medical devices
- Demonstrable practical knowledge of the following:
- Drug container integrity, Parenteral drug delivery (eg: sub-cutaneous, intra-venous, intramuscular, transdermal)

, Statistical Techniques, Jigs and Fixtures design, Instrument Calibration, Equipment qualification - Functional testing and reliability
- Risk Assessment
- Secondary packaging
- Transport studies and validation
- Excellent documentation skills
- Excellent team player, with collaborative and oral/interpersonal/communication skills
- Excellent IT knowledge

Weitere Qualifikationen: Quality assurance professional