Description
Medical Device Senior Technician ExpertIf you are looking for your next step in your professional career, working for a successful, global and well known company, Real Staffing has the ideal opportunity for you.
The company I am recruiting for operates in the life sciences industry and is a market leader in their field. This contract role will last from January until June 2016.
For a position in the region of Basel, we are looking for a Senior Medical Device Technical Expert.
Your tasks would be the following:
- Project planning
- Leading the definition of product requirements for delivery systems and the collaboration with external development partners
- Provide primary packaging and device expertise in a broader cross-functional drug product development team
- 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 and authoring technical documentation
- Managing and monitoring Human Factors Engineering activities
- Planning and monitoring of design verification activities (in-house)
- Ensuring a high quality Design History file and transfering DHF to production
Your profile:
- 3 years min. experience as medical device project leader
- Excellent understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive)
- Experience in design development of drug administration device
- Experience in development of syringe, autoinjector or systems for drug delivery to critical areas is a plus
- Fluency in English is a must. Any other languages are an advantage.
Keywords: Medical devices, Design History File, DHF, Technician, Project Leader
Should this role be of interest for you, please contact Nicolas Vicari at Real Staffing on or