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.
RequirementsThe 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.
- Technical / Cloud Systems Expertise
- Strong understanding of distributed systems including web services, microservices, REST APIs, and service-oriented architectures (SOA).
- Strong understanding of software development life cycle (SDLC), including Agile methodologies and DevOps integration.
- Working knowledge of database systems, data models, data governance principles, and data flow within cloud-based architectures.
- Strong systems engineering expertise including architecture definition, requirements management, trade studies, and risk analysis.
- Experience defining system concepts, performance models, and non-functional requirements (e.g., latency, scalability, reliability).
- Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS).
- Understanding of medical device product life cycles.
- Experience with requirements traceability and verification methodologies across the system development lifecycle.
- Experience with design control processes.
Education and/or Experience- BS Degree in Engineering - Software, Computer, Systems, Electrical, Mechanical or related discipline. Advanced degree desirable.
- Agile or Scrum certifications (e.g., Product Owner) preferred.
- Minimum 7+ years of engineering experience, including at least 2 years in systems engineering roles supporting software or cloud-based products.
Experience in regulated product development (medical device or similar) is strongly preferred. - INCOSE certified systems engineer desirable.
- 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).
Salary RangeAlphatec 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. $125,000 to $140,000 Full-Time Annual Salary
