Beschreibung
Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.We are looking for a
Device Developer (m/f)
Referenz: -en
Beginn: asap
Dauer: 12 MM++
Ort: in Basel region
Branche: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Ihre Aufgaben:
- Evaluation, selection, characterization, interaction and industrialization of medical devices for combination products (e.g., pre-filled syringe, needle safety device, autoinjector, injector pen, infusion pump, new technology, special packaging)
- Application, customization and systems integration
- Provide support for supplier evaluation, contractual, commercial, supply, quality, manufacturing, regulatory, complaint, change and risk aspects as necessary
- Generation of plans, protocols, reports, Design Control, Risk Management, regulatory documents and patents, as required
- Application with parenteral drug products for development, clinical, handling study use and for first commercialization as required by the R&D portfolio, considering required regulatory, legislative, ecological, economical and technical aspects
- Design Transfer into external manufacturing supply chain
- Technology Transfer and introduction of combination products and medical devices into commercial facilities/packaging centers
Ihre Qualifikation
- University level education (preferably with an engineering degree) and track record and experience in medical device, special/innovative packaging or development sector specializing in compact, complex, multi-material hand-held products
- 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 knowledge of drug container integrity, parenteral drug delivery (e.g., sub-cutaneous, intra-venous, intra-muscular, transdermal), human factors engineering, plastics/component engineering, tolerance analysis, design for manufacture, statistical techniques, tooling/equipment qualification, functional testing and reliability, secondary packaging, transport studies and validation
- Demonstrable knowledge of risk assessment tools (e.g. FMEA)
- Demonstrable knowledge of change control procedures
- Excellent command of spoken/written German and English
- Excellent documentation skills
- Excellent collaborative and oral/interpersonal/communication skills
Skills:
- Research Pharma
- Quality Manager Pharma
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