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RORoche

Medical Device Platform Design Engineer(m/w/x)

Basel
Full-timeOn-siteExperienced

Designing Autoinjector and PFS-Needle Safety Device platforms for drug delivery systems. In-depth prefilled syringe and novel drug delivery design knowledge required. Company car for private use, 6 weeks vacation.

Requirements

  • BS in Mechanical Engineering or equivalent technical degree
  • In-depth understanding of prefilled syringes
  • In-depth understanding of Autoinjector
  • In-depth understanding of PFS-Needle Safety Device
  • In-depth understanding of novel drug delivery design
  • In-depth understanding of novel drug delivery manufacturing processes
  • Familiarity with materials science
  • Knowledge of damage mechanisms in drug delivery systems
  • Knowledge of common defects in drug delivery systems
  • Knowledge of performance testing in drug delivery systems
  • Working knowledge of system modeling tools
  • Working knowledge of system modeling methodologies
  • Proficiency with SolidWorks
  • Proficiency with other 3D CAD modeling software
  • Proven track record of technical leadership
  • Proven track record of problem-solving in regulated environment
  • Excellent communication skills
  • Excellent interpersonal skills
  • Excellent collaboration skills
  • Ability to effectively engage with cross-functional teams
  • Ability to effectively engage with external suppliers
  • Ability to effectively engage with industry partners
  • Entrepreneurial spirit
  • Hands-on, roll-up-your-sleeves approach
  • High sense of urgency
  • Dedication to drive for results

Tasks

  • Design and maintain Autoinjector and PFS-Needle Safety Device platforms
  • Support product development and sustaining engineering teams
  • Provide mechanical engineering design expertise
  • Generate concepts and perform engineering analysis
  • Develop internally and externally utilized device design platform technologies
  • Provide technical oversight to external suppliers and partners
  • Drive performance, accountability, and innovation in mechanical design
  • Lead reliability engineering assessments
  • Conduct edge-of-failure testing
  • Manage variance activities
  • Perform tolerance sensitivity assessments
  • Create and maintain Computer Aided Engineering models
  • Develop digital twins for virtual analytical data collection
  • Solve functional and assembly related technical challenges
  • Lead technical investigations at third-party manufacturers
  • Resolve device and assembly issues
  • Lead writing of product and customer requirements
  • Lead design and design phase reviews
  • Lead product and process risk assessments
  • Lead root cause investigations
  • Lead corrective action planning

Work Experience

  • approx. 1 - 4 years

Education

  • Vocational certificationOR
  • Bachelor's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • prefilled syringes
  • Autoinjector
  • PFS-Needle Safety Device
  • novel drug delivery
  • materials science
  • Digital Twins
  • CAE
  • FEA
  • MiniTab
  • SolidWorks
  • 3D CAD
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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