Verification and Validation Engineer I (Medical Devices)

Location: Brisbane, Queensland, Australia

Company

hirify.global is a medical technology company developing clinically differentiated products, services, and integrated technologies for orthopedics and active lifestyles.

What you will do

• Develop, execute, and maintain verification and validation test plans, protocols, reports, test cases, and validation strategies.
• Perform hands-on software and system-level testing for new medical device products and product enhancements.
• Document test results, identify defects, investigate software issues, and verify corrective actions.
• Review requirements, specifications, design documentation, and software documentation for test coverage and compliance.
• Collaborate with Software Engineering, Systems Engineering, Quality, Regulatory Affairs, Product Development, and Program Management.
• Support Agile ceremonies, test automation initiatives, regulatory submissions, quality audits, 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.
• 2–3 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 the software development lifecycle and software 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 with Agile software development environments, defect tracking, test management, and requirements management tools.
• Familiarity with FDA Quality System Regulation 21 CFR Part 820, IEC 62304, ISO 13485, and other medical device standards.
• Understanding of software architecture, design patterns, application logs, and basic debugging.
• Knowledge of musculoskeletal anatomy and orthopedic medical devices.

Culture & Benefits

• Full-time role within an enabling technology and cross-functional engineering environment.
• Participation in Agile development practices, including stand-ups, sprint planning, backlog refinement, and retrospectives.
• Minimal travel as business needs require.
• Focus on scientific excellence, product quality, regulatory compliance, and improved patient outcomes.