Software Engineer – Medical Device Product Development

QvalFocus Inc. is seeking a Software Engineer with strong product development experience to support the development and maintenance of software systems used in medical device platforms. The role involves designing, developing, debugging, and maintaining software for both existing and next-generation medical device products while ensuring compliance with quality and regulatory requirements.

Responsibilities:

• Design, develop, and maintain software for medical device products and platforms
• Implement new product features and support enhancement of existing systems
• Develop software aligned with product design and system architecture
• Work within Agile / Scrum development environments
• Support continuous integration and automated build pipelines
• Identify, troubleshoot, and resolve complex software issues
• Support development of software test plans and collaborate with test engineers
• Create and maintain software requirements, design documentation, and technical specifications
• Ensure documentation supports regulatory and internal compliance requirements
• Work closely with Design Assurance, Regulatory Affairs, Clinical Affairs, and Quality teams
• Support engineering changes and product improvements
• Contribute to development of new products and improvements to existing systems
• Participate in product roadmap discussions and technical design reviews
• Provide technical guidance and mentorship to junior engineers
• Support adoption of engineering best practices and quality standards

Requirements:

• 5+ years of software development experience in product development environments
• Strong programming skills in C++, C#, .NET, or similar object-oriented languages
• Experience with software architecture, algorithms, and data structures
• Experience debugging and troubleshooting complex systems
• Familiarity with version control systems (Git, SVN, Azure DevOps, etc.)
• Strong understanding of software development lifecycle