Senior Software Engineer
St. Louis Park, MNย
Job Summary:
We are seeking aย Senior Software Engineerย with specialized experience in developing software for active implantable medical device systems.ย This role involves creating robust, secure, and scalableย programmingย softwareย andย mobile applicationsย thatย 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.ย ย
Responsibilities:
- Design, develop, andย maintainย programmerย software for medical device systems, including embedded componentsย andย mobile apps (iOS/Android).
- ย Build secure and user-friendly mobile applications for clinicians and patients toย monitorย and interact with implantable devices.
- Collaborate with cross-functional teamsโhardware engineers, firmware developers, and clinical specialistsโto ensure seamless integration betweenย 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.
- Optimizeย 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 generationย andย intelligent code review.ย ย
Required Qualifications: - Bachelorโs orย Masterโs degree in Computer Scienceย orย Computer Engineering, or a related field.
- 5+ years of experience developing software for medical devices or regulated systems.
- Strongย proficiencyย in programming languages such as C/C++, C#, Python, Java, or Swift/Kotlin for mobile development.ย
- Experience with embedded systems and real-time operating systems (RTOS) as well as application-level development.ย
- Familiarity with medical device regulations (FDA, ISO 13485, IEC 62304).ย
- Hands-on experience with wireless communication protocols (BLE) and secure data transfer.ย
- Experience with software development tools (GitHub, Jira) and automated testing frameworks.ย
Preferred Qualifications:- 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.ย ย
Total Compensation: $150,000-165,000 DOE
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