Description

Own the validation and testing lifecycle for medical device software, ensuring compliance with FDA 21 CFR Part 820, EU-MDR, and ISO 13485 regulations.

This role is on-site.

Responsibilities

• Execute unit, integration, verification, and system testing in compliance with IEC 62304 standards.
• Perform non-product software validation and maintain code repositories using C/C++ and C#.
• Collaborate with developers to produce concise, unambiguous design and test documentation.
• Conduct hands-on lab testing and generate detailed technical reports.
• Implement static and dynamic unit test tools to ensure code quality and reliability.

Required Skills

• Bachelor’s degree in Computer Science, Software Engineering, or related engineering field.
• Minimum 2 years of experience in software testing or validation.
• Proficiency in C/C++ programming and ability to read C# code.
• Knowledge of FDA 21 CFR Part 820, EU-MDR, and ISO 13485 compliance.
• Familiarity with IEC 62304 software lifecycle methodologies.
• Experience with static/dynamic analysis tools and version control systems.
• Strong documentation, lab testing, and communication skills.

Preferred Skills

• Advanced degree (Master’s or PhD) in Computer Science, Data Science, Physics, or Engineering.
• Experience with cardiac anatomy, interventional cardiology, or clinical trials.
• Proficiency in Python and Qt framework.

Key Skills

Education

Bachelor's degree