Medical Devices Development Expert

We are looking for a Medical Devices Development expert to support devices development projects for parenteral delivery systems, eg drug/device combination products with main focus on devices for parenteral administration.

Requirement for the role are:

. Master degree in Science/Engineering or Mechanical Engineering. Experience in leading packaging/device/combination product projects;
. Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive);
. Experience in Product design and Design for manufacture;
. Experience of managing external suppliers;
. Good technical knowledge of primary containers development;
. General understanding of Human Factors Engineering and Risk management
. Good understanding of pharmaceutical development in general

Main Tasks:

. Deliver project according to planned timelines,resource and budget;
. Plan and lead technical activities;
. Manage technical development activities in collaboration with internal stakeholders as well as in the projects teams;
. Lead 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.

Please send your CV to Beata Klecz on (see below).

Michael Bailey International is acting as an Employment Business in relation to this vacancy.