Principal Design Engineer

F. Hoffmann-La Roche AG; Basel; Vor Ort; CHF 100.000 - 140.000; Vollzeit

Zusammenfassung

F. Hoffmann-La Roche AG in Basel seeks a technical expert for their Device Development function. This role involves engaging cross-functional teams and establishing robust product requirements for drug delivery devices.

The ideal candidate has over 10 years of experience in mechanical engineering and drug delivery device development, with hands-on expertise in pen injectors. Strong communication skills and knowledge of regulatory standards are essential.

Qualifikationen

• Minimum 10 years proven experience in mechanical engineering and drug delivery device development in regulated environments.
• Hands-on expertise in pen injector / auto injector development.
• Knowledge of tolerance analysis and statistical techniques.

Aufgaben

• Act as a technical expert to bring combination products and medical devices to market.
• Apply advanced engineering theory to establish robust technical product requirements.
• Author design control documentation and conduct conformity assessments.

Kenntnisse

Mechanical engineering

Drug delivery device development

CAD construction

Simulation (FEM, Monte Carlo)

Reliability engineering

Documentation skills

Interpersonal communication

Ausbildung

University-level education in engineering or related discipline

Jobbeschreibung

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.

Responsibilities

• 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 ISO13485, 21CFR820, ISO14971, 21CFR820.30 compliance.

Qualifications

• 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.

Equal Opportunity Employer

Roche is an Equal Opportunity Employer.