Senior Software Engineer

Senior Software Engineer
St. Louis Park, MN


Job Summary:
We are seeking a Senior Software Engineer with specialized experience in developing software for active implantable medical device systems. This role involves creating robust, secure, and scalable programming software and mobile applications that interface with implantable devices. The ideal candidate will have experience in medical device development, system integration, and regulatory compliance, with a passion for building technology that improves patient outcomes.


Responsibilities:

• Design, develop, and maintain programmer software for medical device systems, including embedded components and mobile apps (iOS/Android).
• Build secure and user-friendly mobile applications for clinicians and patients to monitor and interact with implantable devices.
• Collaborate with cross-functional teams-hardware engineers, firmware developers, and clinical specialists-to ensure seamless integration between device, software, and external systems.
• Implement secure communication protocols (e.g., Bluetooth Low Energy, proprietary RF) for data exchange between implantable devices and mobile apps.
• Ensure adherence to medical device standards such as ISO 13485, IEC 62304, and FDA regulations throughout the software lifecycle.
• Optimize software for performance, reliability, and cybersecurity in a highly regulated environment.
• Conduct risk analysis, debugging, and verification to ensure software meets safety and efficacy requirements. Document design specifications, test plans, and validation reports per regulatory requirements.
• Support clinical trials and post-market activities by analyzing system performance and deploying software updates.
• Apply AI-based techniques for code development and process improvement, including automated code generation and intelligent code review.

• Bachelor's or Master's degree in Computer Science or Computer Engineering, or a related field.
• 5+ years of experience developing software for medical devices or regulated systems.
• Strong proficiency in programming languages such as C/C++, C#, Python, Java, or Swift/Kotlin for mobile development.
• Experience with embedded systems and real-time operating systems (RTOS) as well as application-level development.
• Familiarity with medical device regulations (FDA, ISO 13485, IEC 62304).
• Hands-on experience with wireless communication protocols (BLE) and secure data transfer.
• Experience with software development tools (GitHub, Jira) and automated testing frameworks.

• Experience with mobile app development for healthcare applications.
• Familiarity with Agile development methodologies.
• Knowledge of battery management systems and low-power optimization for connected devices.