Software Quality Engineer

Job Summary

A company is looking for a Software Quality Engineer in the field of Software Engineering.

Key Responsibilities:

• Manage software quality of medical devices, including application software, embedded software, platform software, and operating system software
• Ensure compliance with regulatory standards and guidance such as FDA design controls, IEC standards, ISO standards, and EU Medical Device Regulation
• Evaluate software engineering activities throughout the development process, including requirements analysis, design, integration, verification, validation, and release

Remote Qualifications:

• Bachelor's degree in Computer Engineering, Electronics, or Electrical Engineering
• Minimum of 7 years of relevant work experience in software or quality engineering in medical device development
• Minimum of 2 years of experience in software quality management of Class 2 or Class 3 medical devices
• Experience interpreting and applying industry standards for medical device development, such as ISO 13485, IEC 62304, IEC 82304, FDA 21 CFR 820.30, and EU Medical Device Regulation
• Experience with AI/ML based medical device software quality management is preferred