Verification and Validation Engineer (Medical Devices)

Location: Austin, Texas, United States

Company

hirify.global is a medical technology company developing clinically differentiated solutions and integrated technologies for orthopedics and related applications.

What you will do

• Develop, execute, and maintain verification and validation test plans, protocols, test cases, and reports for software and system requirements.
• Perform hands-on testing for new medical device products and enhancements, document results, and identify defects.
• Investigate software issues with development teams, support root cause analysis, and verify corrective actions.
• Collaborate with Software Engineering, Systems Engineering, Quality, Regulatory Affairs, Product Development, and Program Management.
• Participate in Agile ceremonies, track testing progress, and communicate project risks, issues, and status.
• Support test automation initiatives, quality system activities, regulatory submissions, and continuous improvement of V&V processes.

Requirements

• Bachelor's degree in Biomedical Engineering, Software Engineering, Computer Engineering, Electrical Engineering, Computer Science, or a related engineering discipline.
• At least 5 years of experience in software verification and validation, software quality assurance, or medical device development.
• Experience working in a regulated industry, preferably medical devices.
• Knowledge of software development lifecycle and verification and validation methodologies.
• Experience creating test plans, test protocols, test cases, and verification reports.
• Strong technical writing, analytical, organizational, and cross-functional communication skills.

Nice to have

• Experience in Agile software development environments.
• Familiarity with FDA Quality System Regulation 21 CFR Part 820, IEC 62304, ISO 13485, and other medical device standards.
• Experience with defect tracking, test management, and requirements management tools.
• Basic debugging skills, including application log review and software troubleshooting.
• Knowledge of musculoskeletal anatomy and orthopedic medical devices.

Culture & Benefits

• Collaborative, cross-functional engineering environment focused on scientific excellence and patient outcomes.
• Agile development environment with participation in stand-ups, sprint planning, backlog refinement, and retrospectives.
• Minimal travel as business needs require.
• Equal employment opportunity and reasonable accommodation practices.