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Manufacturing Engineer II
Ref No.: 17-24358
Location: San Jose, California
Qualifications: •BS/MS in mechanical engineering with 3-5 yrs medical device industry experience •Comprehensive knowledge in microfluidics-based biomedical or diagnostic device manufacturing •Extensive experience with equipment for bonding and assembly, particularly ultrasonic welding, laser welding, and adhesive bonding. •Experience in shop tool and machine shop practices, practical use of tools, and ability to do machining and construction of fixtures and breadboard instruments. •Experience in surface modification and etching systems, including plasma treatment and UVO3, is a plus. •Knowledge in specific engineering methodologies, including SPC, PFMEA, Design For Manufacturability, and DOE. Familiarity with Minitab is a plus. •Familiarity with FDA regulatory standards for medical devices, cGMP/QSR/PMA/ISO compliance. •Must have experience in device documentation, including verification test protocols and work instruction documents. •Experience in Solidworks, LabVIEW and MATLAB. Knowledge of GDT is a plus. •Excellent written and oral communication skills. •Excellent interpersonal and interdisciplinary teamwork skills. •Creative, energetic, goal-oriented professional who can work in a multidisciplinary environment

Responsibilities: •Design, fabrication and/or procurement and integration of mechanical and fluidic system components •Develop and implement manufacturing processes to meet product specifications •Develop and implement methodologies to monitor, control and correct manufacturing processes •Apply technical knowledge to the production of micro-fluidic assemblies and components •Develop solutions through DOE, data analysis and other engineering tools. •Create CAD models, assemblies, and drawing using Solidworks CAD system. •Create requisite test procedures and test reports to meet manufacturing needs. •Maintain organized archive of all design concepts and files. •Perform dimension and tolerance analysis on part assemblies. •Participate and contribute to the decision-making process. •Collaborate with scientists and engineers in other disciplines evaluating component and overall system performance. •Participate in facilitated training and development programs designed to increase knowledge in issues related to medical device manufacturing and development •Assist in the design and construction of test fixtures and prototypes to accomplish assigned project and testing goals. •Work with Engineering team and outside suppliers to ensure specification contains proper level of detail required to provide quality product. •Documentation of work, analysis of data, verification testing and reporting/presenting results