Description
We are looking for a
Medical Device Senior Technical Expert - Combination Products (m/f)
Reference: -en
Start: asap
Duration: 6 MM+
Place: in Basel
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- 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)
Your qualifications
- 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
Skills:
- R&D scientist
Keywords: Scientist R&D