Qualifications

• Bachelor's or Master's in Computer Science, Computer Engineering, or a related field.
• 5+ years in software development for medical devices or regulated systems.
• Proficient in C/C++, C#, Python, Java, or Swift/Kotlin for mobile development.
• Experience with embedded systems and real-time operating systems (RTOS).
• Familiar with FDA regulations and standards like ISO 13485 and IEC 62304.
• Hands-on with wireless communication protocols like BLE.
• Experience using software tools like GitHub and Jira, including automated testing frameworks.

Responsibilities

• Design, develop, and maintain software for medical device systems, including mobile apps.
• Build secure mobile applications for clinicians and patients interacting with implantable devices.
• Collaborate with hardware engineers, firmware developers, and clinical specialists for seamless integration.
• Implement secure communication protocols for data exchange between devices and mobile applications.
• Ensure compliance with medical device standards throughout the software lifecycle.
• Optimize software for performance, reliability, and cybersecurity in a highly regulated setting.
• Conduct risk analysis and verification to meet safety and efficacy standards, documenting all processes.

Benefits

• Opportunity to work on technology that improves patient outcomes.
• Engagement with cross-functional teams including hardware and clinical specialists.
• Exposure to regulatory compliance in the medical device industry which enhances credibility.
• Support for clinical trials and real-world application of software solutions.
• Inclusion of AI-based techniques for innovative development processes.