Software Engineer- New product development (Medical device)

QvalFocus Inc. is seeking an experienced Software Engineer to support new product development and commercialization for Class III medical devices. This role will focus on software design, development, verification & validation, design transfer, manufacturing readiness, and commercialization activities while ensuring compliance with FDA regulations and IEC 62304 standards in a regulated environment.

Responsibilities:

• Design, develop, test, and maintain software applications for new medical device products
• Support commercialization activities, including design transfer, product release, and manufacturing readiness
• Create and maintain software requirements, architecture, design documentation, and traceability
• Support software verification & validation (V&V), integration, and testing activities
• Perform software risk analysis and support cybersecurity requirements
• Collaborate with engineering, quality, regulatory, manufacturing, and product development teams throughout the product lifecycle
• Ensure compliance with IEC 62304, FDA regulations, and Design Control requirements
• Support troubleshooting, product enhancements, and continuous improvement initiatives

Requirements:

• Bachelor's degree in Computer Science, Software Engineering, or related field
• Experience supporting new product development and commercialization within Class III medical devices or regulated environments
• Strong knowledge of IEC 62304, FDA regulations, Design Controls, and SDLC processes
• Proficiency in C#, Java, Python, C++, or similar programming languages
• Experience with software testing, V&V, risk management, design transfer, and technical documentation
• Strong analytical, problem-solving, and communication skills