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1201 F. Hoffmann-La Roche AG
3mo ago

Senior Device Engineer(m/w/x)

Basel
Full-timeOn-siteManagement

Description

As a Senior Device Engineer, you will lead projects to bring innovative medical devices to market, ensuring they meet rigorous performance and regulatory standards while effectively managing resources and timelines.

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Requirements

  • •University level education in engineering or related discipline
  • •Minimum 5 years proven track record in mechanical engineering and drug delivery device development
  • •Hands-on Pen injector / Auto injector development expertise
  • •Sound knowledge of legislation, regulation, industry standards, and guidance for combination products and medical devices
  • •Experience with Health Authority interactions
  • •Demonstrable knowledge of drug delivery devices and parenteral drug delivery
  • •Excellent documentation, presentation, and interpersonal communication skills
  • •Excellent command of English; proficiency in German preferable

Education

Bachelor's degree

Work Experience

5 years

Tasks

  • •Lead projects and teams to launch combination products and medical devices
  • •Evaluate new and breakthrough technologies
  • •Establish robust technical product requirements
  • •Develop engineering design solutions for device performance
  • •Author design control documentation, including development plans and specifications
  • •Create and maintain design verification plans and DHF documentation
  • •Conduct conformity assessments and manage risk documentation
  • •Forecast and plan resource demands for device development projects
  • •Execute projects within time, quality, and cost constraints
  • •Ensure designs comply with regulatory standards, including ISO 13485 and 21CFR820

Languages

English – Business Fluent

German – Basic

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