Process Engineer III

Position Description:

At Cholestech, our goal is simple: We want people to live longer, healthier and more active lives. We fulfill that goal by providing easy to use, quick and accurate screening and monitoring of disease and disorders in alternate care sites. Today, the Cholestech LDX System is the only way to measure cholesterol from every possible parameter, all from a drop of whole blood and with the results available in less than five minutes. For the future, we’re hard at work developing new tests and diagnostics systems for other illnesses, such as diabetes, liver and kidney disease.Put Your Passion to Work, become a part of the Inverness team! We are currently seeking a Process Engineer III for Cholestech, a division of Inverness Medical Innovations/BioSite located in our Hayward, California site. The Process Engineer III position will provide technical expertise and tactical coordination for successful implementation of components, processes and equipment for production of cassette-type Class II diagnostic devices. This position will be responsible for process development and successful product launches, with robust manufacturing processes. Performs experimental characterization of the dependence of product performance on raw-material and manufacturing-process variability, including reagent composition, component dimensions, equipment-related factors, process-related factors, and storage/handling. Evaluates results against product design inputs to generate raw-material and process specifications and product-release criteria. Conducts activities required to generate/maintain design-control documentation (e.g., hazard/failure analyses, trace matrices, system requirements documentation) for products and processes, per QSR requirements. Investigates product-performance issues and drives corrective actions that may include raw-material, chemistry, process and test-related enhancements. Responsible for validation of equipment and processes (IQ, OQ, PQ), including derivation of success criteria from product claims, statistical development of experimental test plans, authoring of protocols and reports, execution of experimental activities, and analysis of data vs. success criteria.

To apply, please visit - Inverness Medical Innovations

Qualifications:

BS in Engineering or equivalent plus 5 years engineering experience with in vitro diagnostic devices. Thorough understanding of chemical and mechanical processes for in vitro diagnostic devices. Mechanically inclined, hands-on orientation and practical laboratory skills. Skilled at experimental design, derivation of success criteria, statistical data analysis and interpretation of results. Ability to apply innovative concepts to complex problems. Solid understanding of industry Regulatory and Quality standards (QSR / ISO 9000) for measurement of product performance levels and regulatory compliance.***To apply for this position at Cholestech, a division of Inverness Medical Innovations, Inc., please visit the Inverness/Biosite Career Center using the link http://www.biosite.apply2jobs.com/ Biosite is one of the Inverness companies and houses all of our current job opportunities***