Position Summary:

We are seeking a Sr. Systems Engineer who will play a critical role in defining, integrating, and validating complex intraoperative neuromonitoring systems. This role goes beyond traditional requirements management-you will own system-level behavior, ensuring that software, hardware, robotics, and imaging, and disposables components work together seamlessly.

You will operate at the intersection of disciplines, driving system architecture and interface definition, analyzing performance, and resolving cross-functional challenges. This position requires strong technical depth, systems thinking, and the ability to translate between commercial, engineering, clinical, and regulatory domains.

Essential Functions:

Requirement Management

• Translating business and clinical needs into system requirements
• Perform system decomposition to subsystem requirements
• Maintain Requirement trace matrix

System Architecture & Integration

• Define and maintain system-level architecture across software, hardware, and disposables subsystems
• Own system interfaces, data flow, and interactions between services, devices, and user interfaces
• Evaluate design tradeoffs across performance, usability, accuracy, and reliability

Intraoperative Neuromonitoring

• Support development and validation of IOM system
• Coordinating the interoperability of IOM with Excelsius Navigation and Robotic systems

Coordinate Systems & Accuracy

• Develop and analyze system-level accuracy metrics
• Support quantitative performance characterization and statistical analysis of system performance & accuracy

System Performance & Risk Management

• Analyze system performance including latency, synchronization, and real-time behavior
• Work across distributed components
• Identify and mitigate system-level failure modes and edge cases
• Responsible for Risk Management

Design History File

• Define the DHF architecture
• Ensure traceability from requirements through verification and validation in alignment with design controls
• Collaborate on risk analysis activities in accordance with ISO 14971

Cross-Functional Leadership

• Coordinate technical activities across software, hardware, clinical, regulatory, and manufacturing teams
• Translate complex technical concepts across disciplines to enable effective decision-making
• Troubleshoot complex system-level issues spanning multiple subsystems
• Lead the field issue investigation triage board

Continuous Improvement

• Drive improvements in system design, development processes, and engineering workflows
• Support root cause analysis and corrective actions for system-level issues observed in testing or the field
• Create Design of Experiment (DoE)

Compliance

• 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 upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
• Support the submission

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

Qualifications:

• Bachelor's degree in engineering (Mechanical, Electrical, Biomedical, Software, or related field)
• 5+ years of experience in complex system development (medical devices, intraoperative neuromonitoring, robotics, or similar)
• Strong understanding of systems engineering principles and product development lifecycle
• Experience working across software and hardware domains
• Ability to decompose complex systems and reason about interactions between subsystems
• Excellent communication skills with the ability to work across multidisciplinary teams

Preferred Qualifications:

• Experience with medical devices and FDA-regulated development processes
• Familiarity with IOM, surgical navigation, robotics, or image-guided systems
• Exposure to real-time systems, distributed architectures, or hardware communication protocols
• Experience with system-level validation, statistical analysis, or performance characterization
• Experience with Risk Analysis and FMEAs

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.