Principal Firmware Engineer - Implantable Medical Devices

Enterra Medical, Inc.; Minneapolis (MN); Híbrido; USD 130.000 - 160.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Embedded systems

C/C++

RTOS

Bare-metal programming

Low-power wireless (BLE)

GitHub

Jira

Static analysis testing

Cybersecurity basics

Educación

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

Herramientas

GitHub

Jira

PC-Lint

GTest

Descripción del empleo

Principal Firmware Engineer - Implantable Medical Devices

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

Company Summary:

Enterra Medical is a medical device company dedicated to a singular focus: helping more people with chronic gastroparesis live better lives by advancing technology, expanding clinical science, and accelerating access to the Enterra® Therapy.

Position Overview

We are seeking a skilled Principal Firmware Engineer with specialized experience in developing firmware for active implantable medical devices. This role involves designing, developing, testing, and optimizing embedded software to ensure the safety, reliability, and performance of cutting-edge medical technologies. The ideal candidate will have a strong background in embedded systems, real-time operating systems, and regulatory compliance for medical devices.

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, 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.

Qualifications

• Education: Bachelor’s or master’s degree in electrical engineering, Computer Engineering, Computer Science, or a related field.
• Experience:
  • 7+ years of experience developing firmware for embedded systems, with at least 5 years focused on active implantable medical devices required.
  • Proven expertise in programming in C/C++ for resource-constrained environments required.
  • Experience with real-time operating systems (RTOS) and bare-metal programming.
  • Familiarity with medical device regulations (e.g., FDA, ISO 13485, IEC 62304).
  • Hands‑on experience with low‑power wireless communication protocols (e.g., BLE, Zigbee).
  • Experience using software development tools such as GitHub and Jira.
  • Experience conducting static analysis and unit testing using tools such as PC-Lint and GTest.
• Skills:
  • Strong understanding of embedded systems architecture and hardware-software integration required.
  • Proficiency in debugging tools (e.g., JTAG, oscilloscopes, logic analyzers).
  • Knowledge of cybersecurity principles for medical devices, including encryption and secure data transfer.
  • Ability to work in a highly regulated environment with a focus on safety and quality.
  • Excellent problem‑solving skills and attention to detail.
  • Demonstrated ability to translate business needs into clear technical requirements.
  • Proven ability to mentor and lead a team of engineers in implementing those technical requirements
• Preferred:
  • Knowledge of battery management systems for implantable devices.
  • Familiarity with Agile development methodologies.

Salary: $130,000-160,000 DOE