Senior Scientist
Current• Led system-level development, verification, and validation testing of three (3) PCR-based NeuMoDx Molecular System software versions, including creating test plans on Polarion and preparing technical reports• Evaluated and collaborated with internal and external partners to close 93 high-level customer complaints in Salesforce• Wrote and reviewed IFUs, system software verification technical documentation, and risk assessments for a combined ten (10) IVDD, IVDR, and 510(k) medical… Show more • Led system-level development, verification, and validation testing of three (3) PCR-based NeuMoDx Molecular System software versions, including creating test plans on Polarion and preparing technical reports• Evaluated and collaborated with internal and external partners to close 93 high-level customer complaints in Salesforce• Wrote and reviewed IFUs, system software verification technical documentation, and risk assessments for a combined ten (10) IVDD, IVDR, and 510(k) medical device regulatory submissions• Created and managed eight (8) change control requests, including updating required QMS documentation (e.g., work instructions (WKI), standard operating procedures (SOP))• Documented 192 various system issues in JIRA and coordinated investigations• Developed and executed multiple sessions of five (5) distinct online and in-person comprehensive system-level trainings for new hires and senior-level internal laboratory personnel Show less
