Enterra Medical

Develops implantable gastric electrical stimulation therapy

Principal Firmware Engineer - Implantable Medical Devices

Embedded EngineeringConfirmed live in the last 24 hours

Full-timeMinneapolis, MN, USA$130k - $160k

About the Job

Requirements

A bachelor's or master's degree in electrical engineering, computer engineering, computer science, or a related field.
At least 7 years of experience developing firmware for embedded systems, including at least 5 years focused on active implantable medical devices.
Proven expertise programming in C/C++ for resource-constrained environments.
Experience with real-time operating systems and bare-metal programming.
Familiarity with medical device regulations, including FDA regulations, ISO 13485, and IEC 62304.
Hands-on experience with low-power wireless communication protocols such as Bluetooth Low Energy and 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.
Strong understanding of embedded systems architecture and hardware-software integration.
Proficiency with debugging tools such as JTAG, oscilloscopes, and logic analyzers.
Knowledge of cybersecurity principles for medical devices, including encryption and secure data transfer.
Ability to work in a highly regulated environment focused on safety and quality.
Ability to translate business needs into clear technical requirements.
Ability to mentor and lead a team of engineers in implementing technical requirements.

Responsibilities

Design, develop, and test firmware for active implantable medical devices, ensuring high reliability and performance under strict power and size constraints.
Collaborate with hardware engineers, software developers, and regulatory specialists to integrate firmware with device hardware and external systems.
Implement and validate communication protocols, including Bluetooth Low Energy and proprietary radio frequency, for secure data transmission between active implantable devices and external interfaces.
Ensure compliance with medical device standards, including 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.

Desired Qualifications

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

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

About the Company

Enterra Medical

Develops implantable gastric electrical stimulation therapy

Enterra Medical develops and sells the Enterra Therapy system, a gastric electrical stimulation device used to treat drug-refractory gastroparesis. The system uses a small implantable neurostimulator in the lower abdomen and two leads placed in the stomach wall to deliver mild electrical pulses that help reduce nausea and vomiting, with stimulation adjusted by a physician and reversible if needed. Enterra Medical operates independently with Medtronic as an operational partner, continuing development like the Enterra II MR Conditional system and the newer Enterra ReliaStim lead to improve placement and MRI compatibility. The goal is to improve quality of life for patients with gastroparesis by providing a safe, adjustable, and reversible therapy when diet and medications have failed, and to expand applicable indications through ongoing research.

Company size: 51-200
Company stage: Early VC
Total funding: $19.5M
Headquarters: Minneapolis, MN
Founded: 2022

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