Beschreibung
We are looking for a
Medical Device Development Project Lead (m/f)
Reference: -en
Start: 06/17
Duration: 6 MM++
Place: in Basel
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Deliver project according to plan at project milestones
- Plan and lead technical activities
- Manage technical development activities in collaboration with internal stakeholders as well as in the projects teams
- Lead the collaboration with external development partners
- Monitor work progress according to plan
- Monitor, support and challenge technical development as well as test and verification work
- Monitor development and implementation of manufacturing processes
- Coordinate and monitor technical documentation
Your qualifications
- Master degree in Science/Engineering or Mechanical Engineering or university level Engineering education
- Experience in leading packaging/device/combination product projects
- Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive)
- Experience in product design and design for manufacture
- Experience in managing external suppliers
- Experience in leading device development of parenteral delivery systems, e.g. drug/device combination products with main focus on devices for parenteral administration
- Good communication and conflict solving skills
- Good technical knowledge of primary containers development
- General understanding of human factors engineering and risk management
- Good understanding of clinic studies processes and requirements
- Good understanding of pharmaceutical development in general
- Experience in ophthalmic application device development
- Excellent skills in English are required
Skills:
- Product manager