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Engineer III
Ref No.: 18-08615
Location: South San Francisco, California
The contractor (engineer) is expected to be onsite 5 days per week to support project activities and meetings. Depending on the project, the engineer may be required to attend meetings within the 7 am to 6 pm time frame to accommodate international time zones. Some travel is expected and any travel will require prior management authorization. The engineer will be expected to enroll in required training based upon business/project need.
The engineer is responsible for design, development, and implementation of drug delivery devices for parenteral pharmaceutical therapeutics. Primary technologies include vial transfer systems, manual injection systems, automated injection systems, and interfaces with pre-filled syringes. The engineer is a technical expert and provides technical leadership in the development and commercialization of new drug-device combination products in collaboration with Genentech's engineering, scientific, and manufacturing organizations. The engineer will work with his/her team to ensure that device design, component selection, manufacturability and test methods meet product needs.
Responsibilities include drafting Design Control documents including reports, protocols, plans & specifications, conducting and participating in/leading root cause analyses, participating in cross-functional teams, managing design verification testing and evaluation of device design, assembly & test equipment. He/She will drive problem-solving activities using state of the art tool such as DMAIC, DFFS, DOE, Monte Carlo Simulation, Probabilistic Design.
The engineer regularly interfaces with staff and leaders in Device Development and may interface with Commercial Marketing, Clinical Sciences, Contract Manufacturing, Product Core Teams, Pharmaceutical Development, Packaging Development, Quality and Regulatory Affairs. The engineer may also interact with external development partners and component suppliers.

Experience in full cycle (concept – commercialization) of medical device development, system engineering, injection molding and mold-flow analyses, mechanical modeling methods, medical device risk management, medical device design control requirements, test method development and validation.
Experience in the Pharmaceutical, Biotech or Medical Device industry is a must, with previous work on development of injection devices required. Prior experience working on primary containers, needle safety systems, injection devices with automated features, and container-device compatibility and interactions is highly desired. A proven track record of working effectively in a matrix organization with a highly cross-functional and collaborative environment is very desirable. Excellent communication skills are required.