Principal Firmware Engineer

This role leads the design, development, and testing of firmware for active implantable medical devices, ensuring exceptional reliability and performance under strict power, size, and regulatory constraints. You will provide technical leadership, own the implantable device firmware architecture, and collaborate closely with cross-functional teams to deliver safe, secure, and innovative medical technology. This position offers the opportunity to shape critical product decisions, drive best practices in systems and firmware engineering, and make a direct impact on patients' lives within a mid-size company known for strong technology and a collaborative culture., * Design, develop, and test firmware for active implantable medical devices, ensuring high reliability, safety, and performance under tight power and size constraints.

• Collaborate with hardware engineers, software developers, systems engineers, regulatory specialists, and program management to integrate firmware with device hardware and external systems.
• Implement, validate, and maintain secure communication protocols such as Bluetooth Low Energy and proprietary RF for data transmission between implantable devices and external interfaces.
• Assist in the design, development, and testing of non-production software tools that support verification, validation, and testing of active implantable medical devices.
• Ensure firmware development complies with relevant medical device standards and regulations, including FDA and IEC requirements, throughout the product lifecycle.
• Apply and maintain an understanding of cybersecurity requirements for connected medical devices and incorporate them into firmware design and implementation.
• Optimize firmware for low-power operation to extend device battery life and support long-term operation of active implantable devices.
• Document design specifications, implementation details, test plans, test results, and validation reports in accordance with regulatory and quality system requirements.
• Perform static and dynamic code analysis, code reviews, and other design assurance activities to ensure high-quality, maintainable, and safe firmware.
• Own the implantable device firmware architecture and design, making key technical decisions and guiding the overall system structure.
• Work with systems engineers and program management to decompose system-level requirements into detailed firmware requirements and design elements.
• Conduct design reviews of team members' work products, providing constructive feedback and technical guidance to ensure adherence to standards and best practices.
• Support clinical trials and post-market activities by analyzing device performance data and implementing firmware updates or improvements as needed.
• Support the product lifecycle from concept through verification, validation, transfer to manufacturing, and post-market support, ensuring smooth transitions between phases.
• Apply rigorous risk management practices, including hazard analysis and FMEA, to all designs and ensure that risk controls are effectively implemented in firmware.
• Establish, promote, and continuously improve best practices in firmware and systems engineering processes to enhance quality, efficiency, and compliance.
• Collaborate with all relevant functions to drive innovation, resolve technical issues, and ensure aligned delivery of high-quality medical devices., This role operates primarily on-site, with an expectation of working four days per week at the company's facility, and the potential for increased flexibility over time. You will work closely with cross-functional engineering and regulatory teams in a collaborative, technology-driven environment focused on developing active implantable medical devices. The team uses modern development tools, including GitHub and Azure-based platforms, along with specialized tools for static analysis, unit testing, and verification of safety-critical firmware. The work involves adherence to medical device quality systems and regulatory standards, with structured documentation and review practices integrated into daily activities.

Advocacy Firmware Visionary Innovation Code Review Reliability Unit Testing Test Planning Cyber Security Clinical Trials Risk Management Microsoft Azure Medical Devices Hazard Analysis Embedded Systems Design Assurance Firmware Updates Technical Issues Programming Tools Health Technology Program Management Workflow Management Systems Engineering Formal Verification Software Development Technical Leadership Firmware Development Constructive Feedback Design Specifications New Product Development Artificial Intelligence Static Program Analysis Communications Security Communications Protocols Dynamic Program Analysis Quality Management Systems Engineering Design Process Verification And Validation Real-Time Operating Systems Product Lifecycle Management Continuous Improvement Process Bluetooth Low Energy (Bluetooth) Failure Mode And Effects Analysis, * At least 8 years of experience developing firmware for embedded systems, with a minimum of 5 years focused specifically on active implantable medical devices.

• Proven expertise in programming in C for resource-constrained embedded environments.
• Experience working with real-time operating systems (RTOS) in embedded applications.
• Familiarity with medical device regulations and standards, including FDA and IEC requirements.
• Hands-on experience with low-power wireless communication protocols such as Bluetooth Low Energy (BLE).
• Experience using modern software development tools and workflows, including platforms such as GitHub and Azure-based development environments.
• Experience conducting static analysis and unit testing using appropriate tools for safety-critical or regulated software.
• Ability to optimize firmware for low-power operation and performance in constrained hardware environments.
• Strong background in designing and integrating firmware for safety-critical or highly regulated systems.
• Demonstrated ability to work effectively with cross-functional teams in a regulated product development environment., * Experience with active implantable medical devices across the full product lifecycle, from concept through post-market support.
• Exposure to cybersecurity considerations for connected medical devices and secure communication protocols.
• Experience participating in or leading design reviews, code reviews, and formal verification and validation activities.
• Familiarity with risk management techniques such as hazard analysis and FMEA in the context of medical devices.
• Experience developing or using non-production software tools to support testing and validation.
• Interest in establishing and advocating for best practices and continuous improvement in systems and firmware engineering.
• Comfort working in a mid-size organization with a strong technology focus and collaborative culture., Advocacy Firmware Visionary Innovation Code Review Reliability Unit Testing Test Planning Cyber Security Clinical Trials Risk Management Microsoft Azure Medical Devices Hazard Analysis Embedded Systems Design Assurance Firmware Updates Technical Issues Programming Tools Health Technology Program Management Workflow Management Systems Engineering Formal Verification Software Development Technical Leadership Firmware Development Constructive Feedback Design Specifications New Product Development Artificial Intelligence Static Program Analysis Communications Security Communications Protocols Dynamic Program Analysis Quality Management Systems Engineering Design Process Verification And Validation Real-Time Operating Systems Product Lifecycle Management Continuous Improvement Process Bluetooth Low Energy (Bluetooth) Failure Mode And Effects Analysis +0 Firmware Engineer Actalent Eden Prairie, MN*Remote I2C Firmware Debugging Visionary Innovation Embedded C Test Automation Packet Analyzer Microcontrollers Time Off Management Firmware Development Hardware Programming Electrical Engineering Artificial Intelligence C (Programming Language) Communications Protocols Engineering Design Process C++ (Programming Language) Real-Time Operating Systems Python (Programming Language) Cross-Functional Collaboration Bluetooth Low Energy (Bluetooth) +0

This is a Contract position based out of Minneapolis, MN. Pay and Benefits

The pay range for this position is $60.00 - $82.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type

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