Senior Software Engineer
Enterra Medical, Inc. · St Louis Park, MN · 5 mo ago
On-siteSales$150k–$165k/yrFull-time
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.
Requirements
- 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.