Principal Design Engineer

The Device Development (Device Engineering) Position

Our Device Development function within Roche Technical Development is responsible for the development and support of drug delivery devices. You will engage cross‑functional teams (QA, Regulatory Affairs, Clinical, Commercial) and report to the Section Head of Device Engineering.

• Act as a technical expert to bring combination products and medical devices to market, evaluate new technologies.
• Apply advanced engineering theory to establish robust technical product requirements and develop reliable design solutions.
• Use Digital Twins to verify devices meet performance requirements across the full product lifecycle.
• Assess design robustness and reliability via simulation‑based methods (finite element analysis, tolerance analysis, predictive engineering tools).
• Leverage expertise in injection molding, tool design, and mold flow analysis for large‑scale production.
• Author design control documentation (Design Development Plans, URS, Design Inputs/Outputs, Design Verification Plans, DHF creation/maintenance), conformity assessments, and risk management documentation.
• Forecast and plan resource demands, execute projects within time, quality, cost constraints using Lean principles.
• Apply regulatory knowledge to ensure designs meet ISO
  13485, 21
  
  CFR
  820, ISO
  14971, 21
  
  CFR
  820.30 compliance.

• University‑level education in engineering or related discipline.
• Minimum 10years proven experience in mechanical engineering and drug delivery device development in regulated environments (cGxP, QSR).
• Hands‑on expertise in pen injector / auto injector development.
• Strong CAD construction, simulation (FEM, Monte Carlo), reliability engineering, material science skills.
• Knowledge of tolerance analysis, statistical techniques, process capability, manufacturing processes.
• Knowledge of legislation and industry standards; experience with health authority interactions.
• Application of Lean management principles in a technical development environment.
• Excellent documentation, presentation, and interpersonal communication skills.
• Excellent command of English;
  German proficiency preferred.

Roche is an Equal Opportunity Employer.