Senior Software Engineer – Medical Device Software

QvalFocus Inc. is seeking a Senior Software Engineer to design, develop, test, and maintain software applications for medical device products within a regulated environment. The role encompasses the full software development lifecycle and requires collaboration with cross-functional teams to deliver safe and compliant software solutions.

Responsibilities:

• Design, develop, test, debug, and maintain software applications for medical device products
• Work across the full SDLC including architecture, design, implementation, testing, and release
• Develop solutions in Agile, Scrum, and CI/CD environments
• Collaborate on test strategies and automated testing with QA/Test teams
• Troubleshoot issues, perform root cause analysis, and implement fixes
• Participate in design reviews, requirements analysis, and technical discussions
• Maintain technical documentation and support regulatory compliance
• Support product enhancements, change controls, and new feature development
• Ensure compliance with safety, cybersecurity, and medical device regulations
• Mentor junior engineers and contribute to technical leadership

Requirements:

• Bachelor's degree in Computer Science, Software Engineering, or related field
• Strong experience in full-stack software development (SDLC)
• Proficiency in C#, .NET, C++, or similar OOP languages
• Experience with Git, Azure DevOps, Linux/Unix, or similar tools
• Strong understanding of software design, algorithms, and debugging
• Good communication and documentation skills
• Experience in regulated or safety-critical environments preferred
• Medical device software development experience
• Knowledge of cybersecurity and secure coding practices
• Experience with automated testing and CI/CD pipelines
• Familiarity with DICOM, HL7, or medical imaging systems
• Experience in V&V and regulatory audit support