Principal Firmware Engineer for Implantable Medical Devices

Enterra Medical, Inc.; Saint Louis Park (MN); Hybrid; USD 130,000 - 160,000; Full time

Job summary

Enterra Medical, Inc. is seeking a Principal Firmware Engineer to lead embedded software for active implantable medical devices.

You will design, develop, test, and validate firmware with a focus on safety, regulatory compliance, and power efficiency. You'll collaborate with hardware, software, and regulatory teams to implement secure communications (BLE/proprietary RF) and ensure ISO 13485 and IEC 62304 adherence throughout the lifecycle.

Qualifications

• 7+ years firmware for embedded systems; 5+ years in active implantable medical devices.
• Proficient in C/C++ for resource‑constrained environments.
• Experience with RTOS and bare‑metal programming.
• Familiar with FDA, ISO 13485, IEC 62304.
• Experience with BLE or BLE/Zigbee wireless.
• Hands‑on with debugging tools (JTAG, scopes).
• Experience with GitHub and Jira.
• Able to work in a regulated safety/quality environment.

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, such as 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 all 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.

Skills

Embedded systems

C/C++

RTOS

Low power

JTAG debugging

Cybersecurity

Regulatory compliance

Team leadership

Education

BSc/MSc in EE/CE/CS

Tools

GitHub

Jira

Job description

Enterra Medical, Inc. is seeking a Principal Firmware Engineer to lead embedded software for active implantable medical devices.

You will design, develop, test, and validate firmware with a focus on safety, regulatory compliance, and power efficiency. You'll collaborate with hardware, software, and regulatory teams to implement secure communications (BLE/proprietary RF) and ensure ISO 13485 and IEC 62304 adherence throughout the lifecycle.