Senior Software Engineer – Medical Devices

QvalFocus Inc. is a company focused on developing software for medical device products. They are seeking a Senior Software Engineer to develop, maintain, and improve software while supporting the full software development lifecycle in regulated environments.

Responsibilities:

• Design, code, test, debug, and maintain software applications
• Support architecture, implementation, CI/CD, and Agile/Scrum activities
• Work on automated testing and troubleshooting
• Perform root cause analysis and corrective actions
• Create technical documentation and engineering records
• Support product enhancements, risk assessments, and testing activities
• Ensure compliance with safety, cybersecurity, and regulatory standards
• Participate in audits, remediation, and quality improvement initiatives
• Mentor junior engineers and provide technical guidance

Requirements:

• Develop, maintain, and improve software for medical device products
• Support full software development lifecycle (design → testing → release → maintenance)
• Work with cross-functional teams in regulated environments
• Design, code, test, debug, and maintain software applications
• Support architecture, implementation, CI/CD, and Agile/Scrum activities
• Work on automated testing and troubleshooting
• Perform root cause analysis and corrective actions
• Create technical documentation and engineering records
• Support product enhancements, risk assessments, and testing activities
• Ensure compliance with safety, cybersecurity, and regulatory standards
• Participate in audits, remediation, and quality improvement initiatives
• Mentor junior engineers and provide technical guidance
• Strong experience in software development lifecycle (SDLC)
• Experience in regulated industries (Medical Device preferred)
• Programming: C#, .NET, C++, OOP concepts
• Tools: Git, Azure DevOps, Visual Studio, Linux/UNIX, RTOS
• Knowledge of software architecture, multithreading, algorithms, and debugging
• Experience with testing, troubleshooting, and documentation
• Strong communication and teamwork skills
• Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, or related field
• Medical device software experience
• Cybersecurity and secure software development knowledge
• CI/CD and automated testing framework experience
• Knowledge of DICOM, HL7, medical imaging, or healthcare systems
• Experience with V&V, audits, remediation, and compliance activities