Systems Engineer II

Alphatec Spine • Carlsbad, CA

4d • Onsite

About The Position

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.

Requirements

• Experience in requirements development, architecture definition, risk management, and verification/validation planning.
• Working knowledge of software development life cycle (SDLC).
• Familiarity with medical device product development life cycles.
• 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.
• 2- 5 years of engineering experience, including 1 year working in Systems Engineering, Systems Architecture, or multi‑disciplinary product development roles.
• Candidates must be authorized to work in the United States without the need for current or future employer sponsorship.

Nice To Haves

• Graduate 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

• 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.
• 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).
• 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.
• 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.

Benefits

• ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws.
• Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level