Design Verification / Test Automation Engineer

About the position

At Orthofix, we are guided by our organizational values - Take Ownership | Innovate Boldly | Win Together. We collaborate closely with world-class surgeons and other partners to improve people's quality of life. Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. In this role, you will establish and implement verification and testing standards for our bone growth therapy (BGT) devices, performing, documenting, and automating verification testing, including hardware, firmware, and App related aspects of the BGT devices.

Responsibilities

• Develop and execute design verification and validation protocols for medical devices and Software per regulatory requirements (FDA, ISO 13485, IEC 60601, ISO 14971, etc.).
• Design and develop test plans, test cases, and test scripts for both software and hardware components of medical devices.
• Set up and operate test equipment, including mechanical, electrical, and software-based systems.
• Perform functional, performance, and reliability testing to ensure compliance with design specifications.
• Analyze test data, identify deviations, and collaborate with design teams for corrective actions.
• Prepare and maintain detailed verification reports, traceability matrices, and risk assessments.
• Ensure verification activities comply with regulatory standards such as FDA 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, and IEC 60601.
• Support the creation of regulatory submissions (510(k), PMA etc.) by providing necessary verification documentation.
• Work closely with design, quality, and manufacturing teams to improve product designs based on test results.
• Participate in design reviews, risk management activities (FMEA), and CAPA investigations.
• Support automation of verification tests to enhance efficiency and repeatability.

Requirements

• Bachelor's or master's degree in biomedical engineering, Electrical Engineering, Mechanical Engineering, or related field.
• 3+ years of experience in medical device verification & validation (V&V).
• Strong knowledge of medical device regulations and standards (FDA, ISO 13485, IEC 60601, ISO 14971, etc.).
• Experience in test method development, test automation, and statistical analysis.
• Proficiency in test equipment, data acquisition tools, and failure analysis techniques.
• Familiarity with risk management tools (FMEA, DFMEA, AFMEA).
• Strong documentation and technical writing skills for regulatory submissions.

Nice-to-haves

• Experience with software verification & validation (IEC 62304) for medical devices.
• Hands-on experience with LabVIEW, Python, MATLAB, or other test automation tools.
• Knowledge of Good Manufacturing Practices (GMP) and Design Control principles.