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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

Projektdetails

  • Einsatzort:

    Basel-City, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    6 MM++

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland