Principal Device Engineer

The role of Principal Device Engineer at Roche involves driving engineering excellence in the development of drug delivery devices. Roche is a global healthcare company focused on developing meaningful medicines and ensuring access to healthcare. The company values personal expression, open dialogue, and genuine connections, fostering an environment where employees can thrive both personally and professionally. The main day-to-day responsibilities include serving as a Technical Project Lead or Subject Matter Expert to drive the development of combination products and medical devices. This involves applying deep engineering expertise to establish robust technical product requirements and developing design solutions. The role also includes collaborating with external partners to provide technical oversight on mechanical designs, leading technical investigations, and authoring comprehensive design control documentation. Additionally, the engineer will navigate the global regulatory landscape to ensure compliance with industry standards. To qualify for this role, candidates must have a university degree (BSc or MSc) in engineering or a related technical discipline. They need 10+ years of experience in mechanical engineering and drug delivery device development within pharma or highly regulated environments. Hands-on expertise in pen injector and autoinjector development, as well as a strong background in container closure systems, is essential. Candidates should also have a solid understanding of materials science applied to drug delivery systems and deep knowledge of global regulations and industry standards for combination products and medical devices. Nice-to-have skills include proficiency in German, as fluency in English is required for this global role. The role is based in a collaborative environment with a focus on innovation and creativity, fostering a culture of high ambition and exploration of new possibilities. What the role asks for: - University degree (BSc or MSc) in engineering or a related technical discipline. - 10+ years of experience in mechanical engineering and drug delivery device development. - Hands-on expertise in pen injector and autoinjector development. - Strong background in container closure systems, specifically prefilled syringes and cartridges for parenteral drug delivery. - Proven technical leadership and advanced problem-solving capabilities in cross-functional team environments. - Solid understanding of materials science applied to drug delivery systems. - Deep knowledge of regulations, industry standards, and guidance for combination products and medical devices on a global scale. - Direct experience navigating Health Authority interactions and managing regulatory submissions. - Technical proficiency in parenteral drug delivery, risk assessment, tolerance analysis, statistical techniques, process capability, and reliability engineering. - Fluency in English.