Software Test Engineer

Job Summary

Leading software test activities in an R&D environment, the full-time Software Test Engineer will focus on software verification and validation for regulated medical devices, ensuring compliance with healthcare industry standards and regulatory requirements in Plymouth, MN.

Key responsibilities

• Conduct software verification and validation for interconnected medical device ecosystems
• Ensure quality and traceability across multiple device platforms while adhering to medical software development processes
• Support compliance with FDA and EU regulatory standards in software testing activities

Required qualifications

• Proficiency in C/C++ programming
• Experience with IEC 62304 software test methodologies
• Knowledge of FDA 21 CFR Part 820 and ISO 13485 compliance
• Familiarity with unit, integration, verification, and system testing
• Experience in software validation for regulated environments