Senior Systems Engineer

The Senior Systems Engineer will lead system design, integration, and software-centric product development for ATEC’s EOS Insight Portal (cloud-connected platform). The successful candidate will drive systems development throughout the product life cycle, partnering closely with cross-functional teams to translate clinical and business needs into scalable, reliable system solutions.

Essential Duties and Responsibilities

This role emphasizes cloud connected systems, requiring a strong understanding of distributed architectures, data pipelines, and software lifecycle integration within a regulated environment.

Serve as a systems engineering lead within a cross-functional team including software, DevOps, data engineering, marketing, clinical, regulatory, and quality.

Drive concept development and system architecture activities, evaluating technologies, and defining scalable cloud-based solutions.

Lead development of user needs, use cases, and system requirements, ensuring traceability and alignment with verification and validation activities throughout the product lifecycle.

Own system level risk management activities, including risk assessments, risk file maintenance, and incorporation of production feedback into future product improvements.

Provide system level impact and safety assessments of component failure modes to inform DFMEA and overall system risk posture.

Guide and author technical inputs for FDA 510(k) submission development or other regulatory filings as assigned.

Work closely with a project manager, or directly manage projects as appropriate, to drive clear timelines that are executed on time and on budget.

Drive verification and validation readiness through clear design documentation, effective test strategies, and early identification of system-level testing needs.

Lead design control activities including phase reviews, DHF management, and change control execution.