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RORoche

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

Basel
Full-timeOn-siteSenior

Leading projects for combination products, evaluating breakthrough medical device technologies. 10-year mechanical engineering track record and combination product legislation knowledge required. Work in a mission-driven environment for global healthcare access.

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

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

Work Experience

  • 10 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent
  • GermanBasic

Tools & Technologies

  • Pen injector
  • Auto injector
  • cGxP
  • Quality System Regulation (QSR)
  • Statistical techniques
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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