Renee Casali

V & V Engineer at Nevro
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Contact Information
us****@****om
(386) 825-5501
Location
Mountain View, California, United States, US

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Experience

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • V & V Engineer
      • Mar 2019 - Present

      • Develop verification and validation test protocols for a system that includes the following: an implantable stimulator and accessories, a device programmer, and Web services. • Development activities include definition of test plans, design and implementation of test protocols, development of automated software verification, and preparing verification and validation reports. • Develop software test protocols in a regulated environment in accordance with internal operating procedures and external standards and regulations. Conduct cross-functional reviews of the software protocol development at appropriate times in the development cycle. • Assess new test technologies via reviews of the state of the art or by performing proof of concept work. The results of this assessment must be communicated to the software team or other members of the development organization. • Work in accordance with quality system procedures and actively enforces its objectives Show less

  • SRC Testing, LLC
    • Mountain View, California
    • Proprietor, SQA Engineer
      • May 2017 - Present

      Contractor with growing, global company which has revolutionized the way liquid handling is done in the life sciences industry. Responsible for writing and executing test cases for software which adds compliance with 21 Part CFR 11 to the front end user applications. Instrumental in documenting IQ/OQ and providing support to tech publications. Contractor with growing, global company which has revolutionized the way liquid handling is done in the life sciences industry. Responsible for writing and executing test cases for software which adds compliance with 21 Part CFR 11 to the front end user applications. Instrumental in documenting IQ/OQ and providing support to tech publications.

    • United States
    • Biotechnology Research
    • Sr. SQA Engineer
      • Jan 2015 - Mar 2019

      Write/update requirements and test plans for user-interface and instrument control software for a first-in-class system for measuring protein conformation change. Build, deploy and debug embedded software. Manage problem reporting system and interact with customers and communicate issues to subcontracted UI developers and DevOps team. Responsible for procurement and validation of OEM system controllers. Maintain User Manuals and set up simulators for conference demos and tech pubs. Write/update requirements and test plans for user-interface and instrument control software for a first-in-class system for measuring protein conformation change. Build, deploy and debug embedded software. Manage problem reporting system and interact with customers and communicate issues to subcontracted UI developers and DevOps team. Responsible for procurement and validation of OEM system controllers. Maintain User Manuals and set up simulators for conference demos and tech pubs.

  • Autonomic Technologies
    • Redwood City, California
    • Consultant - Clinical Studies, QA, R&D
      • Apr 2011 - Dec 2014

      V&V - R&D ATI System verification activities include testing products with new versions of software and firmware, revisions of product requirements and protocols and authoring reports to summarize verification results. Software support and unit test development activities include building up test base using, updating software requirements and authoring reports detailing code coverage metrics. V&V, Clinical Operations Activities include Validation/Verification/UAT Clinical Database and reports, improving and documenting processes, development of tools and acceptance test of tools. Quality Assurance Specialist Activities include processing Document/Engineering change requests, archiving all forms of documentation for audit readiness, facilitating the transition of the current document control system to PLM software. Manage company training system, DHF, inventory logs while verifying accuracy and proper procedures within the company Quality System requirements. Show less

    • United States
    • Education Administration Programs
    • 200 - 300 Employee
    • Technical Staff, School Site Council, Volunteer Coordinator
      • Aug 2003 - Apr 2011

      Member Technical Staff Proactive in improving and managing the school web page through constant collaboration with teachers, staff and PTA. Organize and implement the upgrade of the on-site computer lab. Develop teaching materials for students. Implement training and problem reporting for the school staff. Manage and troubleshoot the MacOS and PC environments. Instrumental in the research, purchase and installation software and hardware for administrative and teaching purposes. Volunteer, School Site Council Served on School Site Council conducting research to evaluate academic standards, spending, school climate, communication and safety. Used Continuous Improvement Model to review problems, identify root cause and analyze results. Made formal recommendations for process improvement. Project Management Volunteer coordinator role involved coordinating 150-300 volunteers in 15+ functions. Routinely asked to continue and sought as a “go-to” person in high-stress situations due to calm delivery and quick problem solving. Organized large meetings and executed large events. Show less

    • United States
    • Software Development
    • 700 & Above Employee
    • Senior Member, Technical Staff - IC Digital CM
      • Jan 1999 - Jan 2003

      Developed and maintained software compilation and integration tools, new and legacy, designed to build, test and package software deliverables for customer consumption. Instrumental in software builds for a number of products in various OS and source code control environments. Managed a web page which documented all job pertinent technical procedures. Collaborated with manufacturing personnel to ensure that software releases were available to customers from the corporate download sites. Developed and maintained software compilation and integration tools, new and legacy, designed to build, test and package software deliverables for customer consumption. Instrumental in software builds for a number of products in various OS and source code control environments. Managed a web page which documented all job pertinent technical procedures. Collaborated with manufacturing personnel to ensure that software releases were available to customers from the corporate download sites.

  • Signal Science
    • Sunnyvale, CA
    • Software Development Engineer
      • Jan 1997 - Jan 1999

      Developed, maintained and re-engineered software containing complex mathematical algorithms and MMI designed for GSM signal processing and geolocation applications. Developed and maintained a library of database interface tools and a relational database GUI that allowed company staff to easily perform document control tasks, inventories (using bar-code peripherals) and report generation. Designed and automated training material for the inventory control tool. Developed, maintained and re-engineered software containing complex mathematical algorithms and MMI designed for GSM signal processing and geolocation applications. Developed and maintained a library of database interface tools and a relational database GUI that allowed company staff to easily perform document control tasks, inventories (using bar-code peripherals) and report generation. Designed and automated training material for the inventory control tool.

Education

  • Santa Clara University
    Bachelor of Science, Computer Science
  • UCSC Silicon Valley Extension

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