Test Engineer at NuVasive responsible for developing effective and reliable test methodology within the Surgical Intelligence business unit. Led planning for and development of various test engineering methodology that contributed to the International launch of the Pulse Platform. Today I continue to lead planning and test methodology development for updates to the Pulse Platform’s software capabilities and integration efforts with new development projects.Key Responsibilities and Accomplishments:-Requirements Development: implement SMART requirements practices (specific, measurable, attainable, relevant, timely) to develop and review requirements.-Test Development and Execution: create test plans with unique methodology to appropriately verify requirements, validate fixtures or software tools, and characterize product reliability (including the determination of sample sizes and confidence and reliability levels).-Test Lead: define scope, timeline, and resources for specific projects, including the management of a small team.-Requirements and Test Management Process Lead: develop strategy, implement roll out, provide cross functional and continuous improvement support for JAMA platform in order to better manage, execute, and show traceability of requirements and test plans.

Overall Responsibility: -Ensured project activities are compliant with Plexus’ Standard Operating Procedures (SOPs), ISO 13485 Quality Management System, and FDA Quality System Regulation (QSR)Project Experience:Breast Biopsy Device Design Verification - Lead Quality Engineer -Reviewed and approved updated verification procedures using customer updated requirements-Performed regression analysis for software and verification procedure updates to assess impacts to verification testing-Coordinated approval and record keeping for Engineering Change Orders (ECOs) Facilitated/Participated in various formal design reviews and verification phase end reviews-Compiled Design History File (DHF) components to supply to customer for regulatory submittalCybersecurity Risk Analysis Tool - Creation and Validation Lead-Developed intended use requirements for Common Weakness Scoring System (CWSS) and Common Vulnerability Scoring System (CVSS) tool-Designed Cybersecurity CWSS and CVSS tool using VBA Macros and embedded functions-Created and executed user validation study with support from local Human Factors Engineer-Performed preliminary risk analysis and created validation plan and protocol for Non-Product Software (NPS) validation-Transitioned NPS validation plan and protocol to independent tester for validation executionCPR Assistive Device - Regulatory Documentation Updates-Performed IEC 60601-1-2 4th edition updates to requirements and instructions for use documentation based on regulatory gap analysisRotational Atherectomy Device - Risk Analysis and Quality Support-Supported Design Failure Modes and Effects Analysis (DFMEA) efforts for device