Description
We are looking for a
Medical Device Technical Expert (m/f)
Reference: -en
Start: 06/17
Duration: 6 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Run and lead technical development activities for medical devices e.g. Autoinjector, Safety syringes
- Generate Design Controls documentation while contributing to a high-quality Design History File (DHF) for parenteral delivery injection systems
- Author and Reviewer of DHF documents
- Ensure quality and compliance to applicable regulations of the DHF elements of the assigned projects
- Ensure device design development in compliance with the regulations and delivered at a high quality
- Consult on the development of medical devices and combination products
- Support DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions
Your qualifications
- Experience in device development of parenteral delivery systems, e.g. drug/device combination products with main focus on medical devices for parenteral administration
- Experience generating DHF documentation, including but not limited to design input requirements, technical specifications, design verification, design validation, and design transfer
- Excellent technical writing skills (e.g., Design Controls)
- Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) and of combination products (US)
- Experience in Product Design and Design for Manufacturing
- Good technical knowledge of primary containers development
- Good technical knowledge of autoinjector development
- General understanding of Human Factors Engineering and Risk management
- General understanding of clinical trial processes and requirements
- General understanding of pharmaceutical development
Skills:
- Project manager