Senior Device Engineer

Roche seeks a Senior Device Engineer in Basel to lead the development of drug delivery devices, ensuring technical excellence, regulatory compliance, and successful product launches.

The Device Development department within Roche Technical Development focuses on creating and supporting drug delivery devices for the company's product portfolio. This position serves as a technical leader or expert, guiding the engineering process from concept to market while ensuring robust design and adherence to global standards.

Responsibilities

• Serve as the technical lead or subject matter expert to launch combination products and medical devices.
• Assess emerging technologies and apply engineering principles to define product requirements and create design solutions that sustain performance over the product lifecycle.
• Provide technical supervision for external partners regarding mechanical designs for combination products, ensuring innovation and robustness.
• Direct internal and external investigations to quickly address design-related issues using structured problem-solving methods.
• Prepare design control documentation, including development plans, user requirements, design inputs/outputs, verification plans, conformity assessments, and risk management records.
• Utilize regulatory expertise to guarantee designs meet standards such as ISO 13485, 21CFR820, ISO14971, and 21 CFR 820.30.

Requirements

• Hold a BSc or MSc degree in engineering or a related technical field from an accredited institution.
• Possess at least five years of mechanical engineering experience in drug delivery device development within pharmaceutical or highly regulated settings (cGxP, QSR).
• Demonstrate hands-on expertise in pen injector and autoinjector development across the full product lifecycle.
• Show a strong background in container closure systems, particularly prefilled syringes and cartridges for parenteral drug delivery.
• Exhibit proven technical leadership and advanced problem-solving skills in cross-functional team environments.
• Maintain a solid understanding of materials science applied to drug delivery systems, including damage mechanisms, defect identification, and performance testing.
• Possess deep knowledge of global regulations, industry standards, and guidance for combination products and medical devices.
• Have direct experience navigating Health Authority interactions and managing regulatory submissions.
• Demonstrate technical proficiency in parenteral drug delivery, risk assessment, tolerance analysis, statistical techniques, process capability, and reliability engineering.
• Display excellent communication skills, strategic thinking, and strong documentation/presentation capabilities to effectively influence stakeholders.
• Be fluent in English for this global role.

Nice to have

• German proficiency is a plus.

About the company

Roche is a global healthcare company with over 100,000 employees dedicated to advancing science to ensure everyone has access to healthcare today and for generations to come. The company fosters a culture of personal expression, open dialogue, and genuine connections, where employees are valued and respected for their unique qualities. Roche empowers its workforce to explore new possibilities, foster creativity, and keep ambitions high to deliver life-changing healthcare solutions.

• The company encourages personal expression, open dialogue, and genuine connections.
• Employees are valued, accepted, and respected for who they are.
• Roche aims to prevent, stop, and cure diseases while ensuring healthcare access.
• The company empowers employees to explore new possibilities and foster creativity.
• Roche is driven by a healthier future and innovation to deliver life-changing healthcare solutions.