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Product Development Engineer (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Design, Engineer
Projektbeschreibung
REFERENZNUMMER:
303188/11
IHRE AUFGABEN:
-Responsibility for the maintenance of existing Technical File and Design History File documentation
-Design Risk und Clinical Risk evaluation, write Design and Clinical Risk Management documents
-Preparation of the required documents to ensure compliance with Medical Device Regulations (EU MDD, US FDA, JP PAL)
-Responsibility for the maintenance of existing implants and instruments
-Write Standard Evaluation EN ISO 14630:2012 and EN ISO 14602:2011
-Information exchange and collaboration with internal, local, external and foreign partners
-Close cooperation with internal departments, domestic and international authorities
IHRE QUALIFIKATIONEN:
-Ability to comprehend existing tech file documentation in English
-Degree in life sciences or equivalent education
-Practical experience in a regulated industry, preferably in a pharmaceutical environment
-Fluent English skills (written and spoken) and basic German skills
WEITERE QUALIFIKATIONEN:
Product manager
303188/11
IHRE AUFGABEN:
-Responsibility for the maintenance of existing Technical File and Design History File documentation
-Design Risk und Clinical Risk evaluation, write Design and Clinical Risk Management documents
-Preparation of the required documents to ensure compliance with Medical Device Regulations (EU MDD, US FDA, JP PAL)
-Responsibility for the maintenance of existing implants and instruments
-Write Standard Evaluation EN ISO 14630:2012 and EN ISO 14602:2011
-Information exchange and collaboration with internal, local, external and foreign partners
-Close cooperation with internal departments, domestic and international authorities
IHRE QUALIFIKATIONEN:
-Ability to comprehend existing tech file documentation in English
-Degree in life sciences or equivalent education
-Practical experience in a regulated industry, preferably in a pharmaceutical environment
-Fluent English skills (written and spoken) and basic German skills
WEITERE QUALIFIKATIONEN:
Product manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik