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NONovartis

Senior Expert Engineering – Assembly for Medical Device(m/w/x)

Basel
Full-timeOn-siteSenior

Developing platforms for drug delivery systems, leading assembly teams for plastic and metal components at a global pharmaceutical company. 5 years development experience for drug delivery systems, with plastic/metal component assembly required. Leadership role in cross-functional assembly teams, end-to-end project involvement.

Requirements

  • Degree in mechanical engineering or equivalent
  • 5 years of experience in medical device development
  • Proficient spoken communication and excellent technical writing skills in English
  • Proven experience in assembly of plastic and metal components / sub-assemblies
  • Proven experience in design for manufacturing and design for assembly
  • Good knowledge in key regulations and standards (e.g. ISO 13485, ISO 23908, ISO 11608, ISO 10993, MDR, Design Controls)
  • Ability to interact with cross functional team in matrix organization
  • Travel to visit suppliers and CMOs

Tasks

  • Develop platforms for drug delivery systems
  • Collaborate with cross-functional teams to ensure product safety and reliability
  • Lead assembly teams for device parts and design equipment
  • Support processes from prototyping to commercial scale
  • Create and maintain Design History File (DHF) documents
  • Contribute to medical device development phases: ideation, prototyping, piloting, and manufacturing transfer
  • Ensure components meet quality standards for clinical trials and production
  • Collaborate with external partners, including prototypers and toolmakers
  • Identify root causes of issues and implement effective solutions

Work Experience

  • 5 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent
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