Principal Design Engineer

Roche seeks a Principal Design Engineer in Basel to lead the development of safe, reliable drug delivery devices, combining advanced engineering with regulatory expertise.

This position sits within Roche’s Device Development function, reporting to the Section Head of Device Engineering. The role focuses on bringing combination products and medical devices to market by integrating design, engineering, testing, and manufacturing disciplines to ensure product safety and reliability.

Responsibilities

• Serve as a technical authority to guide the market launch of combination products and medical devices.
• Evaluate emerging and breakthrough technologies for potential integration into the product portfolio.
• Utilize advanced engineering principles to define robust technical requirements and create dependable design solutions.
• Employ Digital Twin technology to confirm that devices maintain performance standards throughout their entire lifecycle.
• Conduct rigorous reliability and robustness assessments using simulation tools, including finite element analysis (FEA) and tolerance analysis.
• Apply specialized knowledge in injection molding, tool design, and mold flow analysis to optimize designs for mass production.
• Prepare and maintain essential design control documentation, including development plans, user requirements, design inputs/outputs, verification plans, and the Design History File (DHF).
• Manage conformity assessments and risk management documentation in compliance with regulatory standards.
• Plan and forecast resource needs for device development initiatives.
• Deliver projects on time, within budget, and to quality standards by applying Lean management principles.
• Ensure all designs adhere to current regulatory landscapes and industry standards.

Requirements

• A university degree in engineering or a related field.
• At least ten years of experience in mechanical engineering, specifically in drug delivery device development within pharmaceutical or highly regulated sectors.
• Practical experience in developing pen injectors or auto-injectors.
• Strong proficiency in CAD, simulation (FEM, Monte Carlo), reliability engineering, and material science.
• Solid understanding of tolerance analysis, statistical methods, process capability, and manufacturing techniques.
• Familiarity with relevant legislation, industry standards, and experience interacting with Health Authorities.
• Proven ability to apply Lean management principles in technical development settings.
• Exceptional skills in documentation, presentation, and interpersonal communication.
• Fluent command of the English language.

Nice to have

• Proficiency in the German language.

About the company

Roche is a global organization with over 100,000 employees dedicated to advancing science to prevent, stop, and cure diseases. The company strives to ensure access to healthcare for current and future generations, empowering its workforce to explore new possibilities, foster creativity, and maintain high ambitions.

• The workplace encourages personal expression, open dialogue, and genuine connections.
• Employees are valued, accepted, and respected for their individual identities.
• The mission focuses on preventing, stopping, and curing diseases while ensuring healthcare access for all.
• The company supports employees in exploring new possibilities and fostering creativity.