Description

You will focus on the analysis, design, and validation of software through rigorous requirement review and testing protocols.

Responsibilities

• Analyze requirements to create MRS and BRS documentation.
• Develop system-level validation and subsystem-level verification test cases based on MRS, BRS, and UID documents.
• Manage traceability for test environments and requirements to ensure full coverage.
• Prepare test environments using VMs and Citrix for both informal and formal testing phases.
• Conduct internal audits and support external audits for ISO 9001:2015, ISO 13485, FDA, BSI, IEC 62304, and DEKRA.
• Generate verification and validation reports to track engineering and product issues.

Required Skills

• 8+ years of professional experience.
• Bachelor’s degree in Computer Science, Computer Information Systems, Information Technology, or equivalent experience.
• Proficiency with Quality Center, Clear Quest, and Req pro for document control and versioning.
• Experience managing test environments using Citrix and Virtual Machines.
• Experience with clinical automation tools including DICOM Edit, DICOM Compare, and PACS.
• Knowledge of calibration phantoms, water, and glass phantoms.
• Familiarity with regulatory standards including ISO 13485 and IEC 62304.

Key Skills

Education

Any Graduate