Steven Babb

About Steven Babb

ASQ Certified Software Quality Engineering professional with expert knowledge in planning, resourcing, and managing the software quality function. Quality Core Team member and SQE resource for supporting new product development teams in the design of Class medical devices, accessory applications, cloud-based applications, web-based services, and SAMD.More than 25 years’ experience in medical device design and manufacturing- Product Software, Hardware, Electro-mechanical, and firmware (FPGA & PLD) design and development- Sustaining engineering, Field Engineering Support, On-market Software Maintenance Planning- Software Risk Management, Risk Management planning, Risk File Management, determining Level of Concern and Safety Classification, System Hazard Analysis, DFMEAs, HRA’s, HHE’s, Software Risk Assessments, Design Change Impact Analysis, and Regression Analysis- Validation of non-product software tools, development aids, production floor fixtures and harnesses, COTS software used during product development lifecycle- Design Transfer of validated Product from R&D to Manufacturing, Pilot Production, DHF Auditing, and DMR updates.

Experience

1. Principal Software Quality Subject Matter Expert

   Quality Means Business

   Aug 2025 — Present · San Diego, CA, US

   As Principal Software Quality Engineering SME, my primary focus involves supporting, collaborating with. and establishing software quality engineering processes for the development of the architectural design of complex, scalable generative AI software systems and providing technical leadership, mentorship and oversight for ensuring software quality and performance. Key responsibilities include developing and implementing verification and validation solutions, optimizing existing software test assets, collaborating across departments, and staying current with new technologies to drive continuous improvement of quality assurance initiatives.Key Responsibilities • Technical Leadership & Design: o Assisting the Development team in the verification and validation of scalable, high performance generative AI software systems for compliance to applicable regulations. o Collaborating with the development team in establishing software engineering processes for software projects. o Solving complex technical problems and optimizing intricate software systems to maintain compliance. • Mentorship & Guidance: o Providing technical expertise and guidance to junior and mid-level quality engineers. o Mentoring development teams and fostering a culture of continuous improvement and learning • Development & Optimization: o Designing V&V planning and execution, coding, testing, and deploying generative AI software solutions. o Improving the performance and scalability of existing software. o Ensuring software adheres to best practices, security standards, and quality requirements. • Collaboration & Communication: o Working with product managers, designers, and QA engineers to align technical solutions with business goals. o Communicating effectively with both technical and non-technical stakeholders. • Innovation & Strategy: o Researching and recommending new V&V methods and processes. o Contributing to strategic technical planning and roadmaps.

Education

• National University

  Associate of Science - AS, BS, Computer Engineering

Skills

• Quality Assurance
• Public Speaking
• Software Design
• Requirements Analysis
• Validation
• Spc
• Quality System
• V&V
• Test Management
• Integration
• Process Simulation
• Configuration Management
• Quality Management
• Software Development
• Cmmi
• Unix
• Test Automation
• Quality Control
• Test Cases
• Quality Center
• R&D
• Design Control
• Iso
• Fda
• System Testing
• Testing
• Medical Devices
• Capa
• Iso 9000
• Dmaic
• Leadership
• Software Quality
• Software Documentation
• Sdlc
• Root Cause Analysis
• Computer System Validation
• 21 Cfr Part 11
• Software Quality Assurance
• Change Control
• Software Project Management