Senior Device Development Process Engineer

At Roche, 88,500 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 35 years, using human genetic information to develop novel medicines for serious and life-threatening diseases.

Our group is searching for an experienced and dynamic Device Development Process Engineer to be responsible for bringing to production innovative drug delivery devices designed for Genentech’s next-generation drug pipeline. We are looking for an outstanding candidate that is creative, self-motivated, able to deal with uncertainty and perform with grace under pressure. The environment is on the forefront of medical innovation, with technology and scientific challenges, results oriented, and rewarding for high-potential individuals.

* Develop manufacturing processes and guide the design transfer of combination products to the manufacturing sites. * Effectively work with manufacturing sites for the commissioning of the equipment and its use in a GMP environment. * Perform DFx reviews (focus on molding and mechanical assembly processes) of combination products while in development and provide guidance to the design team to ensure successful high-volume manufacturing * Liaise with other Genentech functions: * Business * Quality * Validation * Regulatory * Packaging and Logistics * Oversee equipment design for the assembly, inspection and testing of combination products. * Support transfer of test methods, rationalization of control system (In Process Control, Batch Release, Stability, Design verification) for the manufacturing processes * Support risk management activities such as pFMEAs. * Work with device design partners and vendors, such as equipment suppliers. * Develop and maintain the project schedule, manage resources, liaise with engineering and manufacturing resources in other countries.

* BSME (or equivalent) with 10+ years of experience in process development, design or product transfers of medical devices (combination products a plus). * In depth experience with high volume manufacturing processes and methodologies is required, with emphasis in mechanical assembly. * Ability to interact at a detail technical level with both design engineers, equipment and production engineers. * Familiarity with risk management tools; develop FMEAs of the process and ability to assess changes, non-compliances, etc. with risk assessments methods. * Strong expertise with statistical analysis and interpretation of data. * Effective team worker, particularly with cross functional teams but also able to work independently * Excellent presentation and communication skills (both written and verbal) and experience authoring and reviewing technical reports * Diligent attention to detail