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Medical Device Senior Technical Expert - Oferta z Jobs.pl

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Medical Device Senior Technical Expert

Nr ref.: /JOBS.pl

  • Reference Number: 895101-P

    Type of placement: Contract - 9+ month

    Start date: October 2016

    Location: Basel, Switzerland


    Lead and manage technical activities and apply expertise to address complex design, development, operational issues for the preparation and timely delivery of Primary and Secondary Packaging for combination products, processes and procedures. Compile Design Control documentation and contributing to a high quality Design History File (DHF). Author and Review of DHF relevant documents. Ensure quality and compliance to applicable regulations of the DHF elements of the assigned projects. Consult on the development and/or optimization manufacturing processes for medical devices and combination products.

    Main responsibilities

    Packaging Technology Activities:

    Coordinate packaging development activities with the project team members for assigned projects
    Maintain knowledge in the areas of materials (glass, polymers, rubbers, silicone/lubricants, sterile barrier systems, adhesives). Manufacturing (injection molding, glass converting, rubber molding, assembly, fill & finish, transport validation)
    Develop packaging concepts to support early phase development
    Conduct feasibility assessments on new technology/ packaging concepts
    Develop early and late phase packaging prototypes using rapid prototyping, machined and/or soft tooling
    Conduct design for manufacture assessments
    Conduct tolerance stack analyses
    Maintain technical drawings and models
    Contribute to risk analyses
    Develop Design Input Requirements

    Qualifications and Experience:

    Bachelor degree in a science related subject or other related field
    (3-6 years) of directly related experience as principal scientist or equivalent
    Recognized expertise in a specific area.
    Thorough knowledge of state-of-art technology/equipment/regulation as appropriate for the role.
    Understanding of packaging and medical devices development processes.
    Effective communication and influence skills and leading without authority
    Ability to work effectively in an international multicultural matrix organization
    Fluency in Written and spoken English


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