Description
The successful candidate for this position will lead or support technical activities within the development of parenteral delivery systems, e.g. drug/device combination products and medical devices, within the client’s Device Team with main focus on devices for parenteral administration.Role:
- Compile Design Control documentation and contributing to a high quality Design History file.
- Planning and leading technical activities.
- Managing technical development activities in collaboration with internal development partners.
- Leading 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.
- Leading or participating in Risk management activities.
- Supporting Human Factors Engineering activities.
Requirements:
- Pre-filled-syringe device development, from early phase activities up to commercialization and production scale up.
- Experience in intravitreal drug delivery, medical devices for ophthalmic applications.
- DHF compilation.
- Experience in remediation projects.
- Understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive).
- Mechanical engineering in general.
- Product design/Design for manufacture.
- Test and verification, incl. development of methods and equipment.
- Experience of managing external suppliers.
- Good communication and conflict solving skills.
- Good technical knowledge in primary containers, e.g. syringes and cartridges.
- General understanding of Human Factors Engineering and Risk management.
- Good understanding of pharmaceutical development in general.
- Language: Excellent skills in English language are required.