36 days ago on ctcon.ch

Medical Device Senior Technical Expert

CTC Clinical Trial Consulting AG

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 Please refer to JobSuchmaschine in your application

Medical Device Senior Technical Expert

Reference Number: 895101-W
Type of placement: Contract, 9+ months
Location: Switzerland, North West


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