Poonam Setlur Email & Phone Number

Brentwood, Ca, Us

Pacheco, Ca

As a Project Manager in Biocare Medical's Reagent Research and Development (R&D) Team, I oversee the entire lifecycle of In Vitro diagnostic Medical Device products from concept to launch. This includes providing technical recommendations and troubleshooting support throughout product development, meticulously tracking daily progress, and delivering regular updates on target completion dates to leadership and cross-functional teams. I organize and lead Phase Gate meetings with stakeholders to… Show more As a Project Manager in Biocare Medical's Reagent Research and Development (R&D) Team, I oversee the entire lifecycle of In Vitro diagnostic Medical Device products from concept to launch. This includes providing technical recommendations and troubleshooting support throughout product development, meticulously tracking daily progress, and delivering regular updates on target completion dates to leadership and cross-functional teams. I organize and lead Phase Gate meetings with stakeholders to assess progress and readiness for product transfers across departments. Additionally, I coordinate the seamless transfer of products from R&D through manufacturing, QC, and sales/marketing and meticulously manage Design History File documentation for all products. I successfully launch 10-15 new products and support the launch of 50-100 second-generation products annually. Furthermore, I serve as a key member of the IVDR team, playing an integral role in passing the audit to achieve IVDR certification for CE marking of IVD devices. I currently lead efforts to convert legacy IVD devices to comply with new IVDR regulations. I manage technical documentation preparation, conduct extensive literature reviews, and contribute to updating internal PDLC process to align with IVDR compliance standards, ensuring Biocare remains at the forefront of regulatory compliance and innovation in the medical device industry. Show less

Salt Lake City, Utah, United States

Performed serology, forensic DNA analysis procedures and issued reports for 31 cases, encompassing over 100 samples

Lorton, Virginia, United States

Responsible for performing quality control on all critical reagents used in operations and functioned as a certified Forensic DNA Analyst, processing casework samples. In charge of all reagent and consumable ordering for company.

Master Of Science (M.S.), Forensic Science

Activities and Societies: -Teacher's Assistant- graded quizzes and exams, prepared lab supplies, prepare class notes and paperwork.

Bachelor Of Science (B.S.), Biotechnology

Activities and Societies: Research assistant for Biochemistry department: performed research in epigenetics to code the area of the genome.