Alphatec Spine
Senior Systems Engineer
Carlsbad, California, United States · Senior · Full-time
No sponsorship$125k-$140kDetected 30 days ago
Distributed SystemsDevOpsRESTData EngineeringProduct ManagementProject ManagementAgileSystems EngineeringFDA RegulatoryMedical Devices
About the role
- 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.
Responsibilities
- 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.
- 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.
- 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.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requirements
- Working knowledge of database systems, data models, data governance principles, and data flow within cloud-based architectures.
- The requirements listed below are representative of the knowledge, skill, and/or ability required.
- 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.
- Experience with requirements traceability and verification methodologies across the system development lifecycle.
- Experience with design control processes.
- Advanced degree desirable.
Compensation
- 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. $125,000 to $140,000 Full-Time Annual Salary
Benefits
- Understanding of medical device product life cycles.
- Education and/or Experience BS Degree in Engineering - Software, Computer, Systems, Electrical, Mechanical or related discipline.
- Experience in regulated product development (medical device or similar) is strongly preferred.
Visa & Work Authorization
- At this time, ATEC Spine does not sponsor employment visas for this position
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This listing is sourced directly from Alphatec Spine's careers page and normalized into a canonical job model.