Principal Firmware Engineer - Implantable Medical Devices

Position Overview

Location: Minneapolis, MN Hybrid (In office weekly as needed).

Enterra Medical is a medical device company dedicated to a singular focus:

Key Responsibilities

• Design, develop, and test firmware for active implantable medical devices, ensuring high reliability and performance under strict power and size constraints.
• Collaborate with cross-functional teams—including hardware engineers, software developers, and regulatory specialists—to integrate firmware with device hardware and external systems.
• Implement and validate communication protocols (e.g., Bluetooth Low Energy, proprietary RF) for secure data transmission between active implantable devices and external interfaces.
• Ensure compliance with medical device standards (e.g., ISO 13485, IEC 62304) and FDA regulations throughout the development lifecycle.
• Optimize firmware for low-power operation to extend the lifespan of active implantable devices.
• Conduct risk analysis, debugging, and verification to ensure firmware meets safety and efficacy requirements.
• Document development processes, including design specifications, test plans, and validation reports in accordance with regulatory requirements.
• Support clinical trials and post-market surveillance by analyzing device performance and implementing firmware updates as needed.

Required Qualifications

• Bachelor’s or master’s degree in electrical engineering, Computer Engineering, Computer Science, or a related field.
• 7+ years of experience developing firmware for embedded systems, with at least 5 years focused on active implantable medical devices.
• Proven expertise in programming with C/C++ in resource-constrained environments.
• Experience with real-time operating systems (RTOS), bare-metal programming, and low-power wireless communication protocols (e.g., BLE, Zigbee).
• Familiarity with medical device regulations (e.g., FDA, ISO 13485, IEC 62304) and experience using software development tools such as GitHub and Jira.
• Experience with static analysis and unit testing tools (e.g., PC-Lint, GTest) as well as proficiency with debugging tools (e.g., JTAG, oscilloscopes, logic analyzers).
• Strong understanding of embedded systems architecture, hardware-software integration, and cybersecurity principles for medical devices.
• Ability to work in a highly regulated environment, with excellent problem-solving skills and attention to detail.

Preferred Qualifications

• Knowledge of battery management systems for implantable devices.
• Familiarity with Agile development methodologies.

Benefits & Perks

• Salary: $130,000-160,000 DOE