Lead Medical Device Expert

Our client, a global pharmaceutical organisation, is looking for Medical Device Lead Technical Expert

RESPONSIBILITIES:

Tasks and responsibilities would typically include:

- Thorough project planning
- Leading the definition of product requirements for delivery systems, eg drug/device combination products and medical devices
- 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 - Managing the collaboration with internal development partners and stakeholders
- Provide primary packaging and device expertise in a broader cross-functional drug product development team
- Evaluating and challenging technical solutions
- Supporting and coordinating the manufacturing of clinical material and the production scale up
- Supporting cross functional project teams in the development, review and submission of regulatory dossiers
- Leading Risk management activities
- Managing and monitoring Human Factors Engineering activities
- Planning and monitoring of design verification activities (in-house)
- Leading and authoring technical documentation
- Ensuring a high quality Design History file
- Transfer of Design History File to production

REQUIRED EXPERIENCE

- 3 years min. experience as medical device project leader is required is required.
- Excellent skills in English language are required. Excellent understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) is required.
- Experience in design development of drug administration device is required.
- Experience in development of syringe, autoinjector or systems for drug delivery to critical areas is required.