Senior Systems Engineer

Alphatec Spine•Carlsbad, CA

3h•$125,000 - $140,000

About The Position

ATEC is seeking a Senior Systems Engineer to lead systems‑level design and development for surgical, navigation, and informatics platforms. The successful candidate will guide systems through their full life cycle, including user needs refinement, feasibility assessment, requirements development, technical integration, verification and validation, and design transfer. This role partners closely with mechanical, electrical, software, clinical, and quality/regulatory teams to ensure robust, compliant system architectures and high‑performance product execution. The Senior Systems Engineer will also provide technical leadership across cross‑functional efforts and support the development of junior systems engineers.

Requirements

8–15+ years of engineering experience, including significant hands‑on work in Systems Engineering, Systems Architecture, or multi‑disciplinary product development roles.
Proven track record leading complex engineering projects from concept through verification/validation and release.
Demonstrated ability to mentor junior staff and influence cross‑functional teams.
Experience in requirements development, architecture definition, risk management, and verification/validation planning.
Strong understanding of the Systems Engineering life cycle and software development life cycle (SDLC) for complex, software‑driven systems.
Experience working within FDA 21 CFR 820 / ISO 13485 design control processes.
Strong communication skills with the ability to lead technical discussions, author clear technical documentation, and present effectively to leadership.
Undergraduate degree in an engineering discipline, graduate degree preferred.
Minimum 8 years of engineering experience, including significant hands‑on work in Systems Engineering, Systems Architecture, or multi‑disciplinary product development roles.
For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

Nice To Haves

Bachelor’s degree in engineering or related technical discipline (advanced degree preferred).
Experience with surgical technologies, spine implants, navigation systems, robotics, or intraoperative imaging systems.
Experience in regulated product development—medical device preferred (ISO 13485, ISO 14971, IEC 60601, design controls).
Familiarity with MBSE, SysML, Cameo, or similar systems modeling tools.
INCOSE ASEP/CSEP certification or equivalent.
Experience supporting verification planning, requirements traceability, risk management files, and system‑level contributions to regulatory submissions (e.g., 510(k) documentation).

Responsibilities

Lead the development, decomposition, and management of system and subsystem requirements, consistent with INCOSE‑aligned best practices.
Define system architecture, interfaces, and integration strategies for multi‑disciplinary systems spanning software, hardware, and mechanical components.
Perform trade studies, risk analyses, hazard assessments, and support design control activities for regulated medical devices.
Serve as the technical lead for system behavior, usability considerations, and clinical workflow integration in spine surgery environments.
Support compliance and product safety activities, including IEC 60601 evaluations and other applicable certification testing.
Partner with marketing, clinical, software, hardware, mechanical, test, and quality/regulatory teams to refine user needs and ensure seamless subsystem integration.
Lead cross‑functional design reviews and provide analytical decision support through modeling, simulation, and systems‑level analysis.
Collaborate with Quality and Regulatory to ensure requirements traceability, verification strategy alignment, and submission‑ready documentation (e.g., 510(k) inputs).
Prepare clear and complete design documentation for verification and validation teams and engage early to identify test method needs.
Provide mentorship and technical guidance to junior engineers, reinforcing best‑in‑class Systems Engineering practices.
Lead key engineering efforts as the primary systems owner, 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.
Apply project management discipline to drive schedules, manage risks and issues, coordinate cross‑functional execution, and support program milestones.
Maintain design control documentation including Design History Files and Change Orders.
Develop and manage system requirements for intraoperative imaging, surgical navigation, data analytics, and workflow optimization technologies.
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.