Principal Device Engineer

Roche seeks a Principal Device Engineer in Basel to lead the development of drug delivery devices, ensuring technical excellence, regulatory compliance, and robust product design throughout the lifecycle.

The Device Development department within Roche Technical Development focuses on creating and supporting drug delivery devices for the company's product portfolio. This position provides strategic technical guidance and hands-on engineering to solve complex design challenges, ensuring products meet performance standards and compliance requirements from development through commercialization.

Responsibilities

• Act as the primary technical lead or subject matter expert to guide the development of combination products and medical devices, facilitating their transition into clinical trials and commercial markets.
• Define technical product requirements and design solutions for drug-device combinations, ensuring consistent performance across the entire product lifecycle.
• Provide technical oversight for external partners regarding mechanical designs, promoting innovation and robust performance in combination products.
• Lead investigations into complex design-related issues, utilizing structured problem-solving methods to achieve swift resolutions.
• Create and maintain comprehensive design control documentation, including development plans, user requirements, design inputs/outputs, verification and validation plans, conformity assessments, and risk management files.
• Ensure all product designs and processes adhere to global regulatory standards, including ISO 13485, ISO 14971, and 21 CFR Part 820, with a focus on design controls.

Requirements

• Bachelor's or Master's degree in engineering or a related technical field from an accredited institution.
• Over ten years of experience in mechanical engineering and drug delivery device development within pharmaceutical or highly regulated environments (cGxP, QSR).
• Practical experience in pen injector and autoinjector development across the full product lifecycle.
• Strong background in container closure systems, particularly prefilled syringes and cartridges for parenteral drug delivery.
• Demonstrated technical leadership and advanced problem-solving skills in cross-functional team settings.
• Solid understanding of materials science as applied to drug delivery systems, including damage mechanisms, defect identification, and performance testing.
• Comprehensive knowledge of global regulations, industry standards, and guidance for combination products and medical devices.
• Direct experience interacting with Health Authorities and managing regulatory submissions.
• Proficiency in parenteral drug delivery, risk assessment, tolerance analysis, statistical techniques, process capability, and reliability engineering to address complex issues.
• Excellent communication, strategic thinking, and documentation/presentation skills to effectively influence stakeholders.
• Fluency in English is required 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, accepted, 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 that make a global impact.

• Employees are embraced for their unique qualities, with a culture that encourages personal expression, open dialogue, and genuine connections.
• The company is driven by a mission to prevent, stop, and cure diseases, ensuring global access to healthcare.
• Over 100,000 employees worldwide are dedicated to advancing science and delivering life-changing healthcare solutions.
• The culture empowers employees to explore new possibilities, foster creativity, and maintain high ambitions.