Michael Lambert Email & Phone Number

Cincinnati, Ohio

-Member of two project teams developing surgical ablation devices to treat atrial fibrillation. -Developed protocols/reports, carried out testing, and interpreted experimental results for design verification – mechanical, electrical, and bench tests, including animal labs and cadaver labs.-Designed bench tests to gauge device performance in various use methods.-Attended cardiac surgical cases to gather data and surgeon feedback.-Responsible for the evaluation of returned goods and complaint devices.-Managed multiple tasks and gained independence and responsibility over work in product development.-Experienced in improvement projects and the steps necessary to release changes to devices on the market.-Gained an in-depth knowledge of process validation. Determined when validation was necessary and the steps required to validate any process per FDA guidelines.-Experienced in validating and obtaining the approval required for PMA products.-Developed protocols/reports and oversaw the completion of IQ/OQ/PQs and GR&Rs.-Traveled to outside manufacturers to oversee operations – reducing scrap rates in incoming parts by 40%.-Oversaw multiple pilot builds and participated in process troubleshooting and development.-Established process instructions and trained operators to build systems and subassemblies.