Principal Design Engineer

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

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.

The Opportunity

• 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 Roches 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. ISOCFR820 ISO 14971 and 21 CFR 820.30).

Who You Are

• 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 possess excellent documentation presentation and interpersonal communication skills.

• Languages: You have an excellent command of the English language; proficiency in German is preferable.

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.