Senior Engineer with Pen- / Autoinjector

Roche seeks a Senior Engineer in Basel to lead the development of pen and autoinjector devices, ensuring regulatory compliance and successful market launch.

This position sits within the Device Engineering section of Roche's Device Development function, reporting to the Section Head. The role focuses on combining design, engineering, testing, and manufacturing expertise to create reliable and safe drug delivery devices for the company's product portfolio.

Responsibilities

• Lead projects and teams to successfully launch combination products and medical devices.
• Assess emerging technologies and define clear technical product requirements.
• Create engineering design solutions that ensure consistent device performance over the product lifecycle.
• Prepare and maintain design control documentation, including development plans, user requirements, design inputs/outputs, verification plans, and the Design History File (DHF).
• Plan and forecast resource needs for device development initiatives.
• Deliver projects on schedule, within budget, and meeting quality standards.
• Apply regulatory knowledge to ensure designs meet all compliance standards.

Requirements

• Engineering degree or equivalent qualification.
• At least 10 years of experience in mechanical engineering and drug delivery device development.
• Background in pharmaceutical or highly regulated sectors, adhering to cGxP, QSR, or similar standards.
• Practical expertise in developing pen injectors or autoinjectors.
• Strong understanding of legislation, industry standards, and guidance for combination products and medical devices.
• Experience interacting with Health Authorities.
• Knowledge of drug delivery systems, parenteral delivery, risk assessment, tolerance analysis, statistical methods, process capability, manufacturing processes, and reliability engineering.
• Strong documentation, presentation, interpersonal communication, and strategic thinking skills.
• Fluency in English.
• Proficiency in German is preferred.

About the company

Roche is a global company with over 100,000 employees dedicated to advancing science. The organization's mission is to prevent, stop, and cure diseases while ensuring healthcare access for current and future generations. The culture promotes personal expression, open dialogue, and genuine connections, where employees are valued, accepted, and respected. Roche empowers its workforce to explore new possibilities, foster creativity, and maintain high ambitions.

• Encourages personal expression, open dialogue, and genuine connections.
• Values employees for who they are, fostering acceptance and respect.
• Mission-driven to prevent, stop, and cure diseases and ensure healthcare access.
• Empowers employees to explore new possibilities and foster creativity.
• Over 100,000 global employees dedicated to advancing science.