Description
We are looking for a
Medical Device Technical Expert (NOVJP) (m/f)
Reference: -en
Start: 03/18
Duration: 6 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Lead technical development activities for medical devices used in combination products e.g. auto-injector, safety syringes
- Specify requirements of device components and work with third party suppliers to ensure components are delivered and controlled to the required quality for clinical trials and commercial production
- Report to the Device Project Leader on all technical aspects related to the device development project
- Co-ordinate technical activities with other functions responsible for primary and secondary packaging, human factors engineering, risk management and verification testing
- 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 such as design input requirements, component specifications, design verification plan and verification summary report
- Ensure quality and compliance to applicable regulations of the DHF elements of the assigned projects
- Support DRA to prepare medical device/combination product pre-registration documents and answer health authority questions
Your qualifications
- 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 auto-injector development
- Good organization and communication skills
- General understanding of human factors engineering and risk management
Skills:
- Clinical trial assistant