Lead Firmware Engineer – Implantable Medical Devices

Enterra Medical, Inc.; Minneapolis (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 implantable medical devices. You will design, develop, test, and optimize firmware under strict safety and regulatory requirements, focusing on power, size, and reliability.

You will collaborate with hardware, software, and regulatory teams to implement secure BLE/RF communication, ensure ISO 13485 and IEC 62304 compliance, and mentor a team of engineers through the product lifecycle.

Qualifications

• 7+ years in firmware for embedded systems, with at least 5 years on active implantable devices.
• Proficient in C/C++ for resource-constrained environments.
• Experience with RTOS and bare-metal programming.
• Familiarity with medical device regulations (FDA, ISO 13485, IEC 62304).
• Knowledge of low-power wireless protocols (e.g., BLE, Zigbee).
• Experience with software development tools such as GitHub and Jira.
• Experience conducting static analysis and unit testing with PC-Lint and GTest.

Responsibilities

• Design, develop, and test firmware for active implantable medical devices, ensuring high reliability and performance.
• Collaborate with hardware, software, and regulatory teams to integrate firmware with device hardware and external systems.
• Implement and validate communication protocols (e.g., BLE, proprietary RF) for secure data transmission.
• Ensure compliance with medical device standards (ISO 13485, IEC 62304, FDA regulations).
• Optimize firmware for low-power operation to extend device lifespan.
• Conduct risk analysis, debugging, and verification to meet safety and efficacy requirements.
• Document design specs, test plans, and validation reports per regulatory requirements.
• Support clinical trials and post-market surveillance with firmware updates.

Skills

Embedded systems

C/C++

RTOS

Bare-metal programming

Low-power wireless (BLE)

GitHub

Jira

Static analysis testing

Cybersecurity basics

Education

Bachelor’s or Master’s degree in Electrical/Computer Engineering/CS or related field

Tools

GitHub

Jira

PC-Lint

GTest

Job description

Enterra Medical, Inc. is seeking a Principal Firmware Engineer to lead embedded software for implantable medical devices. You will design, develop, test, and optimize firmware under strict safety and regulatory requirements, focusing on power, size, and reliability.

You will collaborate with hardware, software, and regulatory teams to implement secure BLE/RF communication, ensure ISO 13485 and IEC 62304 compliance, and mentor a team of engineers through the product lifecycle.