David C. Email & Phone Number

San Francisco, Ca, Us

San Diego, Ca, Us

-Lead cross-functional investigation teams on multiple customer complaints affecting world-wide assay performance. Successfully resolved complaints, preserving >$100MM in annual revenue.-Determined scope, impact, and necessity for IVD-product field actions. Ensured risk-appropriate actions were taken to meet product needs and minimize business impact.-Advised leadership and peers on feasibility of new products and improvements to existing products.-Regularly prepared and gave technical presentations to audiences of diverse experience levels and backgrounds.

San Diego, Ca, Us

-Designed, developed, and released automated high-throughput CE-IVD NIPT product. Served as the Assay Lead through the three-year Product Development Process cycle, including risk assessment and mitigation for design, automation, and use.-Invented artificial test material, saving >$100k in annual sample procurement costs. Transferred manufacturing process to third-party vendor for production.

San Diego, Ca, Us

-Developed, verified, and released low-thoughput NIPT product for the European market.-Trained operators on product workflows in 5 countries.-Created and deployed Hamilton STAR automation, doubling commercial lab throughput.

-Performed analysis, on own initiative, greatly increasing assay sensitivity which enabled commercial viability of the Verifi NIPT Assay.-Performed quality control and supervised the collection of clinical trial samples.-Developed EPmotion liquid handling solutions for higher throughput NGS library and pooling and greater sample fidelity.-Authored technical documents including Work Instructions, Verifications, and Studies.-Prepared and fractioned whole-blood samples for downstream processes.-Processed fractioned samples using PCR (including quantitative and digital), NGS library, and STR analysis.