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Medical Device Technical Expert (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Engineering, Design
Projektbeschreibung
REFERENZNUMMER:
286943/4
IHRE AUFGABEN:
-Support the technical development of respiratory delivery systems, from early phase activities up to commercialization and production scale up
-Authoring/edit documents regarding the high quality Design History File, drive it to completion and successfully it transfer into production
-Design verification
-Risk management
-Human-factors Engineering
-Definition of product requirements, e.g. drug/device combination products and medical devices
-Cross functional activities, e.g. review and submission of regulatory dossiers
-Collaboration with development partners and stakeholders
-Development and writing of technical documentation for drug/device combination products and medical devices, including Design Control process and applicable regulatory, QA- and GMP-aspects
IHRE QUALIFIKATIONEN:
-Bachelor's or Master degree in Science/Engineering or Mechanical Engineering or University level Engineering education
-Profound experience in medical device development
-Fluency in English is required as well as excellent writing skills (technical writer)
-Understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive)
-Good understanding of risk management and human-factors engineering
-Good knowledge regarding test and verification activities, incl. development of methods and equipment
WEITERE QUALIFIKATIONEN:
R&D scientist
286943/4
IHRE AUFGABEN:
-Support the technical development of respiratory delivery systems, from early phase activities up to commercialization and production scale up
-Authoring/edit documents regarding the high quality Design History File, drive it to completion and successfully it transfer into production
-Design verification
-Risk management
-Human-factors Engineering
-Definition of product requirements, e.g. drug/device combination products and medical devices
-Cross functional activities, e.g. review and submission of regulatory dossiers
-Collaboration with development partners and stakeholders
-Development and writing of technical documentation for drug/device combination products and medical devices, including Design Control process and applicable regulatory, QA- and GMP-aspects
IHRE QUALIFIKATIONEN:
-Bachelor's or Master degree in Science/Engineering or Mechanical Engineering or University level Engineering education
-Profound experience in medical device development
-Fluency in English is required as well as excellent writing skills (technical writer)
-Understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive)
-Good understanding of risk management and human-factors engineering
-Good knowledge regarding test and verification activities, incl. development of methods and equipment
WEITERE QUALIFIKATIONEN:
R&D scientist
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik