Description

You will execute verification and validation activities for embedded medical device software.

Responsibilities

• Create and maintain test documentation in compliance with FDA, IEC 62304, and ISO 13485 standards.
• Participate in risk management activities to identify software hazards and mitigations.
• Design detailed test cases for functional, integration, regression, and system-level testing.
• Develop automated test scripts for embedded systems using appropriate frameworks.
• Design test environments and fixtures that simulate real-world usage conditions.

Required Skills

• 6+ years of experience in embedded software testing, preferably in medical devices.
• Bachelor's degree in Computer Science, Electrical Engineering, Biomedical Engineering, or a related field.
• Strong understanding of the software development life cycle and the V-model.
• Knowledge of regulatory requirements including FDA, IEC 62304, and ISO 13485.
• Proficiency in embedded software testing and software development.
• Familiarity with embedded software debugging tools and techniques.
• Ability to define test coverage based on software requirements and risk analysis.

Preferred Skills

• Strong analytical and technical writing skills.
• Experience working in cross-functional teams.

Key Skills

Education

Bachelor's degree