The Position Global Technical Development (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, we actively collaborate and develop creative technical solutions to bridge early-stage, late-stage and commercial product needs. The mandate is to expertly deliver the pipeline and supply quality products to patients. The Device Development department within Roche Technical Development is responsible for the development and support of drug delivery devices for the product portfolio. Our activities span a range of engineering disciplines from the requirements definition phase through to commercialization and marketed product support. Device Engineering combines design, engineering, testing, and manufacturing to develop reliable and safe drug delivery devices that meet the needs of patients, healthcare providers and Health Authorities. The opportunity: This hands-on role drives engineering excellence by applying design controls, solving complex device engineering challenges, and providing strategic technical guidance to ensure robust product development and compliance. In this role, you will engage in cross-functional collaboration, particularly with Quality Assurance, Device MSAT, Regulatory Affairs, Pharmaceutical Development, Clinical, and Commercial teams. Serve as the Technical Project Lead or Subject Matter Expert to drive the robust development of combination products and medical devices, ensuring a seamless advancement into clinical phases and commercial market applications. Apply deep engineering expertise and strategic insights, establish robust technical product requirements and develop drug-device combination product design solutions to assure devices maintain the required level of performance throughout the entire product lifecycle. Collaborate with external partners providing technical oversight on mechanical designs for combination products while ensuring high performance, design robustness and fostering innovation. Lead internal and external technical investigations to swiftly resolve complex, design-related issues using structured problem-solving methodologies. Author and manage comprehensive design control documentation - including Design Development Plans, User Requirements Specifications (URS), Design Inputs/Outputs, Verification/Validation Plans, conformity assessments, and risk management files. Navigate the global regulatory landscape to ensure all product designs and processes comply with industry standards, specifically ISO 13485, ISO 14971, and 21 CFR Part 820 (with an emphasis on 820.30 Design Controls).