Systems Engineer II

Posted 10 Days Ago
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Carlsbad, CA, USA
In-Office
100K-110K Annually
Mid level
Healthtech
The Role
The Systems Engineer II leads system requirements development and integration in medical device projects, enhancing surgical technologies through collaboration with cross-functional teams.
Summary Generated by Built In

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. 

Requirements

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    • 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. 

Preferred Qualifications:

    • 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). 

Education and Experience

    • Undergraduate degree in an engineering discipline, graduate degree preferred. 
    • 2- 5 years of engineering experience, including 1 year working in Systems Engineering, Systems Architecture, or multi‑disciplinary product development roles. 

Equal Employment Opportunity & Other Disclosures  

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). 

At this time, ATEC Spine does not sponsor employment visas for this position. Candidates must be authorized to work in the United States without the need for current or future employer sponsorship. 

Salary Range

Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate’s qualifications, education, skill set, years of experience, and internal equity. $100,000-$110,000 Full-Time Annual Salary

Skills Required

  • 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 to lead discussions and author technical documentation
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The Company
HQ: Carlsbad, CA
818 Employees
Year Founded: 1990

What We Do

ATEC Spine is a medical device company dedicated to revolutionizing the approach to spine surgery through innovation. ATEC’s Organic Innovation Machine™ is the greatest concentration of spine know-how in the industry and committed to the creation of clinical distinction. Leveraging 100% spine focus and expertise, we seek to improve spine surgery by rethinking, redesigning and seamlessly integrating the technologies required from the ground up. The innovation that results from that process is being rapidly adopted because, like us, spine surgeons covet informatic and procedural sophistication that enables more predictable, more reproducible care. Our flagship technology, the Prone TransPsoas (PTP™) Procedure, leveraged decades of experience to advance first-generation lateral surgery with a more familiar patient position and elevated neuromonitoring.   EOS imaging, the backbone of ATEC’s informatic ecosystem, provides radiographic imaging, enabling standing, full-body, global alignment assessments. We are further developing EOS technology to elevate spine care with unprecedented capabilities. Our vision is to be the standard bearer in spine. Visit our website for more information: www.atecspine.com

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