Aude NOVACEK
Software Test Manager at ZF Engineering Pilsen- Claim this Profile
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Tchèque Limited working proficiency
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Anglais Full professional proficiency
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Bio
Experience
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ZF Engineering Pilsen
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Czechia
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Motor Vehicle Manufacturing
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300 - 400 Employee
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Software Test Manager
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Dec 2019 - Present
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bioMérieux
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France
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Biotechnology Research
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700 & Above Employee
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Immuno-Assay Project manager
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Sep 2015 - Dec 2019
In charge of development projects on the VIDAS system (interface between software, firmware, connectivity, biology) :- identification of projects organization, resources and deliveries- execution of projects on different levels : detailed planning, follow-up, reporting to management/ stakeholders /steering committee- establishment of project scope (statement, boundaries of project, list of change and issues)- definition of project risk management & mitigation plan- establishment of safety product risk with Project team- management of cross functionnal & multicultural team (including external contractors/partners)- ensure projects are delivered according to the quality/regulatory process (IVD process)- actions prioritization, time to market- involvement in PM departement activitiesKepner Tregoe methodology approachTools : Planisware, Test Track suite
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Médiane Système
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France
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Software Development
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100 - 200 Employee
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System Project Manager (Consultant for BioMerieux)
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Jul 2014 - Aug 2015
Project manager EU on an immuno-analysis system.- In charge of projects on the VIDAS system (interface between software, firmware, connectivity, biology)- Responsible of the product requirements, design developement plan, product risk analysis - Management of the project team- Responsible of planning, budget and milestones according to the IVD design process- Management of Design History File
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Akka Technologies
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Belgium
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Information Technology & Services
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700 & Above Employee
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R&D technical leader & System engineer
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Nov 2011 - Jul 2014
System engineer in mission at bioMerieux, support of VIDAS system (SW, FW, biology)In charge of system investigation, CAPA investigation, verification & validation strategy for support project or evolution of the system.
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FIM Medical
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France
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Medical Equipment Manufacturing
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1 - 100 Employee
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OPTIC project manager
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May 2011 - Nov 2011
Implementation of glare tests on the Visiolite device : intended for occupational health services and preventive medicine specialists.- Project management and coordination of the teams (BE interne, externe, production, SAV, qualité)- Mise en place d'une nouvelle fonctionnalité sur un appareil de dépistage des défauts visuelsIn charge of write the CE mark document and the risk management file according to the Directive CE 93/42 and EN 60601 regulations.
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SAS mediXpert France
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Pharmaceuticals
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1 - 100 Employee
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Chef de projet Biophysique
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Jan 2006 - Apr 2010
Project manager in R&D department (Biophysic).Mechanical simulation (COMSOL, SCILAB) on textil.Implementation of experimental benches (dynamometer, photo).Implementation of GUI interfaces.Patents :- FR 2942130 (A1) - PROCEDE D'EVALUATION DE LA TENUE SUR LE MEMBRE INFERIEUR D'UNE ORTHESE DE CONTENTION VEINEUSE ELASTIQUE TRICOTEE - FR 2955386 (A1) - PROCEDE ET APPAREILLAGE DE MESURE DE L'EPAISSEUR D'UNE ORTHESE DE CONTENTION VEINEUSE ELASTIQUE A L'ETAT TENDU DANS DES CONDITIONS DE PORTER - FR 2963231 (A1) - APPAREILLAGE POUR LA MESURE DE L'EFFORT D'ENFILAGE D'UNE ORTHESE DE CONTENTION VEINEUSE ELASTIQUE SUR UN MEMBRE. - FR 2964558 (A1) - PROCEDE D'EVALUATION DE L'EFFORT D'ENFILAGE SUR UN MEMBRE D'UNE ORTHESE DE CONTENTION VEINEUSE ELASTIQUE TRICOTEE
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stage
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2003 - 2003
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Education
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ISBS
Ingéneur, Biosciences -
Université Paris - Val-de-Marne (Paris XII)
Master's degree, Sciences physiques