Senior Systems Engineer
About the role
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.
Responsibilities
- 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.
- Led 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.
Requirements
- 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.
Qualifications
- 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.
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.
Pay
$125,000 to $140,000 Annual Salary
Schedule
Full-Time