Principal Design Engineer

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The Device Development function within Roche Technical Development is responsible for the development and support of drug delivery devices for the product portfolio. Our activities span a range of engineering disciplines from the requirements definition phase through to commercialization and marketed product support.

The Device Engineering department combines design, engineering, testing, and manufacturing to develop reliable and safe drug delivery devices that meet the needs of patients, healthcare providers and Health Authorities.

• In this role, you will have considerable cross-functional interaction, notably including QA, Regulatory Affairs, Clinical, and Commercial functions. This role reports to the Section Head of Device Engineering and is integrated into Roche’s Device Development function.
• Technical Leadership:
  Act as a technical expert to successfully bring combination products and medical devices to the market. Lead the evaluation of new and breakthrough technologies.
• Engineering Excellence:
  Apply advanced engineering theory to establish robust technical product requirements and develop reliable design solutions. Use Digital Twins to verify that devices consistently meet performance requirements across the full product lifecycle. Rigorously assess design robustness and reliability through simulation-based methods, including finite element analysis (FEA), tolerance analysis, and other predictive engineering tools.
• Design for Manufacturing :
  Leverage deep expertise in injection molding, tool design, and mold flow analysis to ensure designs are optimized for large-scale production.
• Design Control:
  Author design control documentation (Design Development Plans, URS, Design Inputs/Outputs, Design Verification Plans, and DHF creation/maintenance), conformity assessments, and risk management documentation.
• Project Management:
  Forecast and plan resource demands for device development projects. Execute projects within the agreed time, quality, and cost constraints, utilizing Lean management principles to drive efficiency and state-of-the-art results.
• Compliance:
  Apply knowledge of the regulatory landscape to ensure standard compliant designs (e.g., ISO 13485, 21
  
  CFR
  820, ISO 14971, and 21 CFR 820.30).

• Education:
  
  You have a university-level education (engineering degree or related discipline).
• Experience:
  
  You have a minimum 10-year proven track record in mechanical engineering and drug delivery device development in pharma or other closely regulated environments (cGxP, QSR).
• Specialization:
  You have hands‑on Pen injector / Auto injector development expertise.
• Technical Toolbox:
  You possess strong engineering expertise including CAD construction, Simulation (FEM, Monte Carlo), reliability engineering, and Material Science.
• Analytical
  
  Skills:
  
  You have demonstrable knowledge of Tolerance Analysis, statistical techniques, process capability, and manufacturing processes.
• Regulatory Savvy:
  You have sound knowledge of legislation, industry standards, and experience with Health Authority interactions.
• Methodology:
  You have a demonstrated application of Lean management principles in a technical development environment.
• Communication:
  You…