Principal Firmware Engineer - Implantable Medical Devices
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Overview
Schedule
Full-time
Education
Engineering (PE)
Career level
Senior-level
Remote
Hybrid remote
Compensation
$130,000-$160,000/year
Job Description
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 OverviewWe 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.
- 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.
- Preferred:
- Knowledge of battery management systems for implantable devices.
- Familiarity with Agile development methodologies.
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FAQs About Principal Firmware Engineer - Implantable Medical Devices Jobs at Enterra Medical, Inc.
What is the work location for this position at Enterra Medical, Inc.?
This job at Enterra Medical, Inc. is located in St. Louis Park, MN, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Enterra Medical, Inc.?
Candidates can expect a pay range of $130,000 and $160,000 per year.
What employment applies to this position at Enterra Medical, Inc.?
Enterra Medical, Inc. lists this role as a Full-time position.
What experience level is required for this role at Enterra Medical, Inc.?
Enterra Medical, Inc. is looking for a candidate with "Senior-level" experience level.
What education level is required for this job?
The education requirement for this position is Engineering (PE). Candidates with relevant qualifications or equivalent experience may also be considered.
What is the process to apply for this position at Enterra Medical, Inc.?
You can apply for this role at Enterra Medical, Inc. either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.