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Senior Software Engineer

Enterra Medical, Inc.

St. Louis Park, MN

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Agile Programming Methodologies, Android, Artificial Intelligence (AI), Atlassian JIRA, Bluetooth, C Programming Language, C++ Programming Language, Clinical Support, Clinical Trial, Code Reviews, Communications Protocols, Computer Engineering, Computer Firmware, Computer Science, Cross-Functional, Debugging Skills, Develop Methodologies, Documentation Design, Embedded Systems, FDA Requirements, GitHub, Healthcare Software, ISO (International Organization for Standardization), Implants, Information/Data Security (InfoSec), International Electro-Technical Commission (IEC), Internet Security, Java, Kotlin, Low Power, Maintain Compliance, Market Analysis, Medical Equipment, Medical Protocols, Microsoft C# (C Sharp), Mobile Applications, Mobile Applications Development, Patient Care, Performance Analysis, Performance Tuning/Optimization, Process Improvement, Programming Languages, Programming Tools, Python Programming/Scripting Language, Radio Frequency, Realtime Operating System, Regulatory Compliance, Regulatory Reports, Regulatory Requirements, Requirements Management, Risk Analysis, Safety Training, Secure Coding, Security Protocols, Software Administration, Software Development, Software Development Lifecycle (SDLC), Software Engineering, System Integration (SI), Systems Analysis, Test Harness, Testing, Validation Plan, Validation Testing, Wireless Protocols/Standards, iOS
LOCATION
St. Louis Park, MN
POSTED
30+ days ago
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.  
Required Qualifications:
  • 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. 
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.  

Total Compensation: $150,000-165,000 DOE
 

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About the Company

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Enterra Medical, Inc.

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