Principal Design Engineer

Role

Full-time

Permanent

Lead

Engineering

Logistics

Basel

Closes in 30 days

Requirements

10+ yrs exp

Bachelor's

EU/EFTA permit

Skills

Injection moldingFinite element analysis (FEA)Mold flow analysis21 CFR 820Tolerance analysisReliability engineeringISO 13485Risk ManagementLean LeadershipDesign controlsMedical device developmentEngineering degree

Languages

English C2

German

Description

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.

Responsibilities

Act as a technical expert to successfully bring combination products and medical devices to the market.
Lead the evaluation of new and breakthrough technologies.
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.
Leverage deep expertise in injection molding, tool design, and mold flow analysis to ensure designs are optimized for large-scale production.
Author design control documentation (Design Development Plans, URS, Design Inputs/Outputs, Design Verification Plans, and DHF creation/maintenance), conformity assessments, and risk management documentation.
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.
Apply knowledge of the regulatory landscape to ensure standard compliant designs (e.g., ISO 13485, 21CFR820, ISO 14971, and 21 CFR 820.30).

Requirements

You have a university-level education (engineering degree or related discipline).
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).
You have hands-on Pen injector / Auto injector development expertise.
You possess strong engineering expertise including CAD construction, Simulation (FEM, Monte Carlo), reliability engineering, and Material Science.
You have demonstrable knowledge of Tolerance Analysis, statistical techniques, process capability, and manufacturing processes.
You have sound knowledge of legislation, industry standards, and experience with Health Authority interactions.
You have a demonstrated application of Lean management principles in a technical development environment.
You possess excellent documentation, presentation, and interpersonal communication skills.

Company

Roche

Pharmaceuticals

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.