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RO
Roche
2d ago

Principal Device Engineer with Pen- / Autoinjector expertise(m/w/x)

Basel
Full-timeOn-siteSenior

Description

As a technical leader, you will drive the development of life-changing drug delivery devices, from evaluating breakthrough technologies to ensuring every design meets rigorous global standards.

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Requirements

  • •University degree in engineering or related
  • •10-year track record in mechanical engineering
  • •Pen or Auto injector development expertise
  • •Knowledge of combination product legislation
  • •Experience with Health Authority interactions
  • •Knowledge of drug delivery and reliability
  • •Excellent communication and strategic thinking
  • •Excellent English and preferable German proficiency

Education

Bachelor's degree

Work Experience

10 years

Tasks

  • •Lead projects and technical teams to market combination products
  • •Evaluate new and breakthrough medical device technologies
  • •Establish robust technical product requirements using engineering knowledge
  • •Develop design solutions to ensure long-term device performance
  • •Author design control and risk management documentation
  • •Create and maintain Design History Files and conformity assessments
  • •Forecast and plan resource demands for development projects
  • •Execute projects within time, quality, and cost constraints
  • •Ensure designs comply with global regulatory standards

Tools & Technologies

Pen injectorAuto injectorcGxPQuality System Regulation (QSR)Statistical techniques

Languages

English – Business Fluent

German – Basic

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