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Medical Device Technical Expert (NOVJP00025730) (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Design, Engineering
Projektbeschreibung
REFERENZNUMMER:
366109/11
IHRE AUFGABEN:
-Lead technical development activities for medical devices used in combination products e.g. auto-injector, safety syringes
-Specify requirements of device components and work with third party suppliers to ensure components are delivered and controlled to the required quality for clinical trials and commercial production
-Report to the Device Project Leader on all technical aspects related to the device development project
-Co-ordinate technical activities with other functions responsible for primary and secondary packaging, human factors engineering, risk management and verification testing
-Generate Design Controls documentation while contributing to a high-quality Design History File (DHF) for parenteral delivery injection systems
-Author and Reviewer of DHF documents such as design input requirements, component specifications, design verification plan and verification summary report
-Ensure quality and compliance to applicable regulations of the DHF elements of the assigned projects
-Support DRA to prepare medical device/combination product pre-registration documents and answer health authority questions
IHRE QUALIFIKATIONEN:
-Excellent technical writing skills (e.g. Design Controls)
-Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) and of combination products (US)
-Experience in product design and design for manufacturing
-Good technical knowledge of primary containers development
-Good technical knowledge of auto-injector development
-Good organization and communication skills
-General understanding of human factors engineering and risk management
WEITERE QUALIFIKATIONEN:
Clinical trial assistant
366109/11
IHRE AUFGABEN:
-Lead technical development activities for medical devices used in combination products e.g. auto-injector, safety syringes
-Specify requirements of device components and work with third party suppliers to ensure components are delivered and controlled to the required quality for clinical trials and commercial production
-Report to the Device Project Leader on all technical aspects related to the device development project
-Co-ordinate technical activities with other functions responsible for primary and secondary packaging, human factors engineering, risk management and verification testing
-Generate Design Controls documentation while contributing to a high-quality Design History File (DHF) for parenteral delivery injection systems
-Author and Reviewer of DHF documents such as design input requirements, component specifications, design verification plan and verification summary report
-Ensure quality and compliance to applicable regulations of the DHF elements of the assigned projects
-Support DRA to prepare medical device/combination product pre-registration documents and answer health authority questions
IHRE QUALIFIKATIONEN:
-Excellent technical writing skills (e.g. Design Controls)
-Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) and of combination products (US)
-Experience in product design and design for manufacturing
-Good technical knowledge of primary containers development
-Good technical knowledge of auto-injector development
-Good organization and communication skills
-General understanding of human factors engineering and risk management
WEITERE QUALIFIKATIONEN:
Clinical trial assistant
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik