TECHNICAL LEAD IVD INSTRUMENTS-Barcelona
At Company Diagnostics we want to incorporate a Project Director of IVD instruments for laboratory automation projects into our team at our Cerdanyola (Barcelona) work center.
Project Director is the project leader in Series Production for Diagnostics Projects, and also manages the further upgrades and improvements of the Product during the phase.
He/She will coordinate multidisciplinary team that support the Production Series , involving, but not limited to quality, procurement, system and software engineering, logistics and production.
He/She will be oriented to fulfilling the project objectives within the schedule, quality and budget assigned, having full authority and responsibility over the project and its resources.
He/She will also manage or support proposals preparation for this Product line.
Funciones / Tareas / Responsabilidades
-Ensure and support that Production Series and further developments comply with all the applicable regulations (i.e. IVD, CE, FDA among others).
-Monitor and Manage the Product Manufacturing and Supply Chain ensuring the maximum productivity and yield with the required Quality standards.
-Lead the product industrialization or New Product Introduction if applicable.
-Manages risk at project level.
-Manages scope and schedule.
-Manages the project team, coordinating all the related activities, fostering communication and motivation.
-Checks the project team activities are in line with the project objectives, ensuring the coordination between all the parties is optimal.
-Leads the communication and coordination with the customer.
-Defines budgets and negotiates contract change notices.
- Experience in managing several million ? projects in Diagnostic or Medical Devices instruments
- Experience in regulatory aspects, such as In Vitro Devices (IVD) , FDA or CE.
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