Genentech's Device Development group is searching for an experienced and dynamic Senior or Principal Engineer to be responsible for developing innovative drug delivery devices designed for our next-generation drug pipeline. Using state-of-the-art technology, the successful candidate will lead the development of combination products to enable clinical and commercial production in our network worldwide - in collaboration with Genentech's scientific, quality and manufacturing organizations. She/he will work on the creation of leading-edge drug delivery devices, often in collaboration with our development partners worldwide, creating solutions to meet the highest standards for quality and reliability.
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.
Provide technical leadership to support engineering, scientific and manufacturing activities.
Collaborate with his/her team to ensure that device design, component selection, manufacturability and test methods meet product needs.
Contribute significantly to design controls documents, test plans and test execution.
Drive problem solving activities using state of the art tools such as DMAIC, DFFS, DOE, Monte Carlo Simulation, and Probabilistic Design.
Support risk management activities such as dFMEAs.
Interact with staff and leaders in Device Development, Project Core Teams, Early and Late Stage Pharmaceutical Development, Quality and Regulatory Affairs, and with external development partners and component suppliers.
May supervise a staff of up to 2 engineers.
The level of the position will depend on the qualifications of the selected candidate.
Bachelor's degree or higher in Mechanical Engineering or other relevant discipline.
8+ years of experience in development and design of medical devices (combination products a plus); 14+ for the Principal level.
Expertise in development of electro-mechanical medical devices is preferred.
Working knowledge of manufacturing, quality control, preclinical and clinical development and regulatory issues pertaining to combination products is preferred.
Extensive application of relevant modeling, design controls and/or statistical analysis. For example: 1.) Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis, Probabilistic Design; 2.) Full data and statistical analysis (JMP, Minitab) and Design of Experiments.
Design Controls for regulatory compliance & filing (ISO 13485, etc.): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, batch records, etc.
Six Sigma (Green/Black Belt) preferred: DMAIC and DFSS.
Proven track record of working effectively in a matrix organization with cross-functional teams (e.g., device development, regulatory, clinical, quality, and program management) and experience working in a highly collaborative environment
Familiarity with risk management tools.
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.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
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