Systems Engineering

by | May 23, 2017 |

A summary of my experience managing requirements, development, and testing throughout the product development process of multiple products over the past five years:

 

Natera Inc, San Carlos, CA

  • Leading integration efforts as liaison between the assay development, automation engineering, project management, and software engineering teams
  • Defining software workflow processes for automated high-throughput DNA extraction, Next Gen Sequencing, and Sanger Sequencing diagnostic assays for variant screening
  • Driving decisions and aligning laboratory information software system requirements with assay development and high-throughput automation efforts

 

 

Roche Molecular Diagnostics, Pleasanton, CA

  • Worked with quality, business/ lab, and software development stakeholders across US and European sites to define testing strategies for integrated automated software/hardware diagnostic devices
  • Applied both Agile software development methodologies and Waterfall requirements management practices in management of various software testing activities, employing formal requirement management tools like HP-ALM
  • Used Scrum methodology and Kanban board to prioritize software features for test and optimize testing workflow
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Novartis Oncology Companion Diagnostics, Cambridge, MA

  • Determined resource requirements, assembled, and energetically led a cross-functional LIMS Core Team of engineers, biostatisticians, scientists, and program managers in defining software requirements
  • Performed cross-functional Voice of Customer activities to translate user stories into system requirements
  • Worked with engineering team in development, verification and validation of RUO/ IVD diagnostic tests
  • Worked with local and overseas software developers to test, validate and document software requirements for diagnostic qPCR-based molecular assay result analysis
  • Led Cross-Functional Kaizen continuous improvement activities for data handling processes
  • Created and executed Verification & Validation protocols for PMA, IVD, 510K, and CE Mark submission