Beschreibung
We are looking for a
Device Verification Engineer (m/f)
Reference: -en
Start: asap
Duration: 12 MM+
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Practical evaluation, characterization and verification of medical devices for combination products (e.g., pre-filled syringe, needle safety device, auto injector, injector pen, new technology, special packaging)
- Practical evaluation of new and breakthrough technologies
- Development of new test methods
- Implementation and qualification/validation of testing equipment
- Generation of plans, protocols and 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)
- Provide support to Technology Transfer of combination products and medical devices into commercial facilities/packaging centers (specification/method/equipment transfer)
Your qualifications
- Technical education, preferably with an engineering degree
- Experience in practical testing and characterization of medical devices, special/innovative packaging or in the development sector, specializing in compact, complex, multi-material hand-held products
- Experience with working in a pharmaceutical company or other closely-regulated environment, under cGxP, QSR or similar working practices
- Sound knowledge of legislation, regulation, industry standards and guidance in the combination products and medical devices area
- Demonstrable practical knowledge of drug container integrity, parenteral drug delivery, equipment qualification, functional testing and reliability and risk assessment
- Excellent command of spoken/written German and English
- Excellent documentation skills
- Excellent team player, with collaborative and oral/interpersonal/communication skills
Skills:
- Test engineer
Keywords: Softwareentwickler