Description

You own verification and validation processes for complex regulated systems, ensuring compliance with ISO 13485 standards.

This role is on-site.

Responsibilities

• Develop and execute V&V Plans, Protocols, and Reports.
• Maintain requirements traceability and Design History File (DHF) documentation.
• Perform hardware, software, and lab tests on complex electromechanical systems.
• Implement and support test automation for regression and system-level testing.

Required Skills

• 7-10 years experience in system-level V&V for IVD/medical devices or complex electromechanical systems.
• Hands-on protocol design and execution in regulated environments.
• Experience in test automation.
• Bachelor's or Master's degree in Engineering (Electrical, Biomedical, Mechanical, Software).
• Knowledge of ISO 13485.
• Familiarity with ISO 14971.
• Familiarity with IEC 62304.

Preferred Skills

• Wet lab workflow knowledge and understanding of sample handling and reagents.

Key Skills

Education

Bachelor's or Master's degrees