We are searching for an candidate which would have at least 8 years of experience in device development of parenteral delivery systems, e.g., drug/device combination products with main focus on medical devices for parenteral administration. The ideal candidate would have experience generating DHF documentation, including but not limited to design input requirements, technical specifications, design verification, design validation, and design transfer.
- 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.
- 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
- Good communication skills
- General understanding of Human Factors Engineering and Risk management
- General understanding of clinical trial processes and requirements
- General understanding of pharmaceutical development