Medical Product Test Lead

Role & responsibilities

• Lead end-to-end testing activities for medical products.
• Define test strategy, test plans, and quality processes.
• Manage functional, integration, system, regression, and performance testing.
• Ensure compliance with FDA, IEC 62304, ISO 13485, and ISO 14971 standards.
• Perform risk-based testing and maintain RTM coverage.
• Drive defect management, RCA, and quality improvements.
• Lead and mentor test engineers.
• Collaborate with Product, R&D, Regulatory, and Clinical teams.

Preferred candidate profile

• Patient Monitoring Systems
• Diagnostic Equipment
• Healthcare Applications
• HL7 & DICOM
• JIRA / ALM / Azure DevOps / Polarion / DOORS