ATEC is seeking a Systems Engineer II to support the design, development, and integration of next‑generation neuromonitoring, navigation, imaging, and cloud‑connected surgical platforms.
This role contributes across the full product lifecycle—from refining user needs and authoring requirements through technical execution, verification/validation, design transfer, and post‑market investigations—while collaborating closely with mechanical, electrical, software, quality, regulatory, marketing, and operations teams.
The systems developed in this role directly support surgeons in improving surgical accuracy, efficiency, and patient safety in spine surgery.
Essential Duties and Responsibilities
- Systems Engineering Leadership
- Support the development, decomposition, and management of system and subsystem requirements, consistent with INCOSE‑aligned best practices.
- Support system architecture, interfaces, and integration strategies for multi‑disciplinary systems spanning software, hardware, and mechanical components.
- Perform risk analyses, hazard assessments, and support design control activities for regulated medical devices, ensuring system‐level safety mitigations that protect patients and clinical users.
- Maintain and update Design History File (DHF) documentation and support Change Order activities, supporting traceability and compliance required to safely deliver products into clinical use.
- Cross‑Functional Collaboration
- Partner with marketing, clinical, software, hardware, mechanical, test, and quality/regulatory teams to refine user needs, translating surgeon and clinical feedback into system requirements that improve real‑world surgical workflows.
- Support cross‑functional design reviews and provide analytical decision support through modeling, simulation, and system-level analysis.
- Collaborate with Quality and Regulatory to ensure requirements traceability, verification strategy alignment, and submission‑ready documentation (e.g., 510(k) inputs).
- Project & Technical Leadership
- Support key engineering efforts, ensuring alignment with program timelines, risk posture, and business objectives.
- Maintain a strong presence in day‑to‑day project execution—driving structure, clarity, and alignment across cross‑functional engineering teams.
- Work closely with a project manager, or directly manage projects as appropriate, to drive clear timelines that are executed on time and on budget.
- Medical Device / Spine Domain
- Develop and manage system requirements for intraoperative imaging, surgical navigation, data analytics, and workflow optimization technologies, that support increased procedural accuracy, reduced variability, and improved surgical efficiency.
- Support integration of informatics platforms with imaging systems, surgical instrumentation, and intraoperative sensors.
- Ensure system design incorporates key clinical and technical considerations including surgical ergonomics, accuracy, latency, safety, sterilization, cybersecurity, and overall reliability.