Software Engineer

United Consulting Hub is seeking a highly motivated and detail-oriented Software Engineer specializing in Medical Devices. The role involves designing, developing, testing, and maintaining software applications for Medical Device systems while ensuring compliance with industry standards and collaborating with cross-functional teams.

Responsibilities:

• Design, develop, enhance, and maintain software applications using C#, .NET Framework, and .NET Core technologies
• Develop software solutions for Medical Device systems, diagnostic platforms, healthcare applications, or laboratory systems
• Participate in the complete Software Development Life Cycle (SDLC) including requirements gathering, design, coding, testing, validation, deployment, and maintenance
• Develop and maintain desktop, web-based, or enterprise applications using technologies such as ASP.NET, MVC, Web API, WPF, or WinForms
• Work closely with Quality Assurance and Regulatory teams to ensure compliance with FDA, ISO 13485, IEC 62304, and other Medical Device standards
• Create and maintain technical documentation including Software Requirements Specifications (SRS), Design Specifications, Traceability Matrix, Risk Assessments, and Validation documents
• Perform unit testing, integration testing, debugging, and troubleshooting of software applications
• Participate in code reviews and implement best practices for software quality, security, and maintainability
• Support software verification and validation (V&V) activities in compliance with regulated industry requirements
• Integrate software with databases, APIs, instruments, and third-party systems
• Collaborate with hardware, automation, and systems engineering teams for device integration and communication protocols
• Utilize version control systems such as Git, Azure DevOps, or SVN for source code management
• Support Agile/Scrum development methodologies and participate in sprint planning, stand-ups, and retrospectives
• Assist in risk management activities and software hazard analysis
• Troubleshoot production issues and provide ongoing application support and enhancements

Requirements:

• Bachelor's degree in Computer Science, Software Engineering, Information Technology, or related field
• 3+ years of experience in software development using C# and .NET technologies
• Strong experience with .NET Framework, .NET Core, ASP.NET, MVC, and Web API
• Experience developing applications in regulated industries such as Medical Devices, Healthcare, Pharmaceuticals, or Biotechnology
• Knowledge of FDA regulations, IEC 62304, ISO 13485, and software validation processes
• Strong understanding of Object-Oriented Programming (OOP) principles and design patterns
• Experience with SQL Server, Oracle, or other relational databases
• Hands-on experience with version control tools such as Git or Azure DevOps
• Familiarity with Agile/Scrum methodologies
• Strong analytical, problem-solving, and debugging skills
• Excellent written and verbal communication skills
• Experience with WPF, WinForms, Blazor, or cloud-based applications
• Knowledge of HL7, DICOM, OPC, or medical communication protocols
• Experience with automated testing frameworks and CI/CD pipelines
• Familiarity with cybersecurity practices for Medical Devices
• Experience working with embedded systems or device integration
• Understanding of software risk management and cybersecurity standards for Medical Devices