We are seeking a Senior Mechanical Engineer to support development of consumable fluidic devices at Roche Santa Clara to improve device reliability and reproducibility up to and beyond commercialization. The role will be responsible for leading product development efforts on microfluidics & plastic injection components design, and support improvements to the internal production line and external vendor manufacturing process flow through the commercial phase; with special focus on flow cells, rubber and plastic molding, surface chemistry treatment, and final device assembly and packaging. The ideal candidate will have expertise in multiple areas – mechanical design using SolidWorks, consumables product development, product transfer, documentation in a regulated environment (preferred) and a natural curiosity to understand how mechanical/material properties of a device can impact product performance.
Collaborate with engineers and scientists on a cross-functional team to develop a novel fluidic device for a next-generation sequencing platform
Design experiments and drive data collection and analysis activities to inform decisions on key design parameters Collaborate with Research Design Engineers to generate product configuration documentation such as specification and assembly drawings, BOMs with special focus on DFM/A, and GD&T analyses.
Drive the design, installation, and validation of fixtures for assembly and testing processes
Design, fabricate, and implement new tools/fixtures for suppliers and internal manufacturing lines.
Develop the required qualification procedures, maintenance, and ongoing testing/tracking to implement new fixtures.
Design assembly and treatment splits in support of yield, reliability, efficiency and quality improvements
Drive continuous improvement plan (CIP), design for manufacturability (DFM) projects for quality improvement and cost reduction
Support quality compliance, MFG system test, and process improvement projects
Support the coordination between internal and external resources for product transfer
Generating technical documents, including IQ/OQ/PQ, SOPs, URS, Design and Functional Specification, Executed FAT and Site Acceptance Testing (SAT) verification, as well as final reports
Craft process recipe matrices in support of yield, reliability, efficiency and quality improvements
Support development of automated assembly and processing manufacturing line
Support development of increased automation (reporting and process) at high volume manufacturing to match demand increase at appropriate lifecycles
Executing failure analysis investigations, risk impact assessment and root cause investigations
EDUCATION, EXPERIENCE and REQUIREMENTS:
BS in a relevant Engineering discipline with at least 5 years of industry experience, or graduate degree in an engineering discipline with at least 3 years of relevant industry experience
Experience working with development of fluidic devices strongly preferred
Experience using 3D CAD design software (proficiency in Solidworks preferred)
Ability to independently develop proto-tools for automated assembly
Working knowledge of commercial wet treatments to functionalize and/or clean surfaces of device
Must have experience with manufacturing and assembly of complex electro-mechanical devices, preferably of a microfluidic, biological lab-on-a-chip purpose.
Some experience with statistical analysis tools (JMP, Matlab, R)
Some programming experience to iterate on fixtures and tools is desired (Python, Matlab, etc)
Willing to train and mentor junior staff to enable best practices in fluidic design development and assembly process development
Working knowledge of production and quality control procedures used in a manufacturing environment
Medical device/biotechnology industry experience highly preferred.
Exceptional oral and written communication skills. Experience with project management responsibilities is a plus.
Some local/international travel may be required up to 10%.