Based in Orange County, CA our prestigious client, is a leader in providing diagnostic solutions for oncology applications.
In this role, you will lead collaborative efforts between chemistry, hardware, manufacturing, regulatory, logistics and quality teams for each assay integrated into the automated platform at the system level. Scope of work ranges from concept through development to support the product strategy and commercialization effort, including verification and validation, design review and transfer, troubleshooting, traceability, test method development, and reporting.
Educational background with a Masters or Ph.D. in Engineering, Biotechnology, Physics or Chemistry with 5+ years in system-level integration and validation experience with regulatory submissions including IDE, 510(k) with IVD products. Significant contributor in design control and risk management. General and wide range of knowledge related to biotech systems integration including engineering, physiology, biochemistry, physics, statistics, and use of computational analysis.