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CSCSL Behring

Senior Engineer (Drug Delivery Lead)(m/w/x)

Bern
Full-timeOn-siteManagement

Project leadership for drug delivery device packaging and medical devices at biotherapeutics leader. 7+ years in drug delivery device development within pharma or highly regulated environment required. Global cross-functional team collaboration in a matrix organization.

Requirements

  • University level education; ideally a Masters or PhD in Biomedical Engineering, Electrical or Mechanical Engineering or in a related field
  • Minimum of 7 years in drug delivery device development with relevant pharma industry experience or other highly regulated environment
  • Background in development of combination products for respiratory drug delivery
  • Experience in project leadership in a matrix organization
  • Strong organizational and communication skills
  • Experience with regulatory and quality standards and generation of documentation for regulatory agencies

Tasks

  • Plan and execute projects for evaluating and improving packaging materials and medical devices
  • Deliver projects on time, within quality standards and budget constraints
  • Collaborate with global cross-functional teams and external partners
  • Lead coordination of activities and information across functions
  • Apply expertise in Design Controls and Risk Management standards
  • Compile and maintain Design History Files and support design verification
  • Deliver submission-ready packages for regulatory bodies
  • Utilize engineering tools for robust design and device limitation analysis

Work Experience

  • 7 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishBusiness Fluent
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