Christopher Castillo

Software Validation and Compliance

• Led software validation and verification (V&V) in compliance with IEC 62304; ensured adherence to ISO 13485, and FDA regulations.
• Ensured compliance with ISO 13485, FDA 21 CFR Part 820, and ISO 14971, improving regulatory adherence.
• Reviewed specifications and technical design documents to provide feedback for Engineering V&V activities.
  Test Documentation and Fixtures.
• Created and revised comprehensive test plans, test cases, work instructions, SOPs, and validation reports to meet regulatory and quality standards.
• Developed detailed V&V Test Protocols and maintained alignment with Risk Analysis Matrix and Design Control documentation.
• Developed Usability Verification Test Protocols to ensure product meets user needs.
  Cybersecurity and Risk Management
• Conducted validation using VA-Templates, performed Threat Modeling, and executed Security Risk Assessments, ensuring alignment with FDA Cybersecurity Guidance, ISO 27001, and NIST 800-53.
  Defect Resolution and Process Optimization
• Investigated software failures, implementing corrective actions that achieved cost savings exceeding $1 million.
  Testing and Automation
• Executed manual and automated testing (functional, regression, and system-level), optimizing automation tools to improve overall test efficiency.
• Developed, applied, and maintained test methods, equipment, and instruments for medical devices throughout all development and production stages to meet user needs and product requirements.
• Setup/architecture, which included drawings, configurations of devices for testing.
• Involved in reliability and integration tests for prototypes and products.
  Collaboration and Leadership
• Trained new hires and junior testers, providing expertise in good documentation practices (GDP) and Software Processes.
• Developed Manufacturing Process Validation activities for Sustainment and New Product Introduction (NPI) projects (IQ/OQ/PQ, Validation Plans, Sample Size, Testing Forms, and Documentation).
• Participated in Peer Reviews of Code, Test Plans, and Defect Tracking to enhance team performance.

• Identified areas of improvement in existing processes and procedures related to software quality assurance.
• Developed scripts and tools to automate regression tests.
• Produced test scripts for new automated software testing rounds.
• Recreated conditions submitted through client error logs to test performance under circumstances likely to reveal operating system compatibility issues and other desktop environment shortcomings.
• Led software validation projects, managing a team of three entry-level testers to ensure system reliability, security, and performance for web-based applications.
• Developed and executed test scripts and plans for financial software systems, identifying security vulnerabilities and performance bottlenecks in web-based applications.
• Tracked and reported defects, ensuring resolution through collaboration with software development teams.
• Conducted regression, integration, and functional testing for web-based software updates prior to production deployment.
• Managed risk-based testing procedures, ensuring software met industry security and compliance standards for web applications.