Description
We are looking for a
Medical Device Technical Expert (m/f)
Reference: -en
Start: asap
Duration: 8 MM+
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Compile Design Control documentation and contribute to a high quality Design History file
- Plan and lead technical activities
- Manage technical development activities in collaboration with internal development partners
- 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
- Lead or participate in risk management activities
- Support Human Factors Engineering activities
Your qualifications
- Master degree in Science/Engineering or Mechanical Engineering or University level Engineering education
- Experience in pre-filled-syringe device development is beneficial
- Experience in intravitreal drug delivery, medical devices for ophthalmic applications
- Experience in DHF compilation
- Understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive)
- Experience in product design/Design for manufacture
- Good communication and conflict solving skills
- Excellent English language skills
Skills:
- Medical affairs manager
Keywords: Medical Affairs Manager