Position Summary:

The Senior Firmware Engineer will develop and deliver reliable, compliant, and high-quality embedded firmware for implantable medical devices and accessories used in spinal cord injury repair, over the full firmware lifecycle, ensuring system integrity, patient safety, and regulatory compliance. This role will serve as a technical influencer-driving firmware architecture decisions, shaping development practices, and guiding cross-functional teams toward robust, scalable solutions.

Essential Functions:

Firmware Development

• Design and implement embedded and PC-based software that interfaces with implantable stimulators and external accessories.
• Define software requirements, create detailed designs, implement and test code, and perform verification and validation in accordance with internal and external standards.
• Investigate, debug, and analyze device issues in complex system interactions during development, verification, and commercialization.
• Support deployed products by identifying root causes and implementing corrective actions to ensure continued device reliability and patient safety.
• Influence software and system design decisions by providing expert insight into firmware architecture, performance trade-offs, and integration risks.

Regulated Software Development

• Develop software in compliance with company procedures, FDA regulations, and international standards (e.g., IEC 62304, ISO 13485, ISO 14971).
• Conduct and participate in cross-functional design and code reviews throughout the development lifecycle.
• Advocate for best practices in software, safety, traceability, and documentation across the development organization.

Technical Leadership

• Serve as a key technical contributor who influences project scope, technical trade-offs, and long-term platform strategies.
• Operate independently with minimal supervision, identifying and mitigating development risks proactively.
• Plan, coordinate, and execute significant firmware projects or multiple smaller projects with complex features, leveraging internal and external resources.
• Guide the transition of advanced technologies into production products, ensuring interface integrity across all system components.
• Mentor junior engineers and peers, fostering a culture of technical excellence, collaboration, and continuous improvement.

Innovation and Technology Assessment

• Evaluate new technologies through literature reviews and proof-of-concept efforts, communicating findings and recommendations to the broader development organization.
• Contribute to the company's intellectual property base through invention disclosures and collaboration with management on new concepts.
• Proactively identify opportunities to apply emerging technologies or methods that improve system performance, development efficiency, or reliability.

Quality and Process Discipline

• Work in accordance with quality system procedures and actively support continuous improvement initiatives.
• Ensure deliverables meet safety, performance, and compliance objectives throughout the development cycle
• Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
• Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
• Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications:

• B.S. in Computer Engineering, Electrical Engineering, or related field.
• Minimum 4 years of experience in software design for embedded systems is required.
• Experience working in high-reliability or regulated industries such as medical devices, automotive, or aerospace preferred

Proficiency in C for embedded systems is required.

• Knowledge of Assembly, C++, C#, Rust and other relevant development languages is also desired.
• Hands on experience with ARM microcontrollers and wireless communication technology is preferred.
• Hands-on experience with oscilloscopes, bus analyzers and logic analyzers is required.
• Knowledge of software lifecycle standards and regulatory requirements (IEC 62304, ISO 13485, FDA QSR).
• Experience with implantable medical device development and functional familiarity with FDA submissions preferred.
• Demonstrated ability to influence technical direction, drive cross-functional decisions, and lead by example in a regulated environment.

Strong communication and collaboration skills to align engineering, quality, and clinical objectives.

Physical Demands:

The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.

• Required to sit; climb or balance; and stoop, kneel, crouch or crawl
• Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds

Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.