Systems Engineer II jobs in United States
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ATEC Spine · 1 day ago

Systems Engineer II

ATEC Spine is a company focused on surgical navigation and robotics systems. The Systems Engineer II role involves supporting the design, development, and integration of these systems, collaborating with various teams to ensure system requirements are met and verified throughout the product life cycle.

Health CareMedical DeviceProduct Design
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H1B Sponsor Likelynote

Responsibilities

Support the definition and characterization of system-level accuracy for surgical navigation and robotics platforms, ensuring alignment with clinical, regulatory, and business requirements
Contribute to the design, construction, and characterization of navigated arrays and surgical instruments under established design guidelines
Collaborate with internal stakeholders (clinical research, marketing, surgeons, etc.) to help capture, document, and refine user needs and system requirements
Support concept and early-phase development activities, including feasibility testing and technology evaluations
Develop and execute system and sub-system tests during development, and support formal verification and validation activities
Assist with compliance and certification testing (e.g., IEC 60601-1) under guidance from senior engineers and quality/regulatory partners
Maintain and update Design History File (DHF) documentation and support Change Order activities
Work closely with a project manager, or directly manage projects as appropriate, to drive clear timelines that are executed on time and on budget
Lead or support the execution of Design Control Phase reviews
Be a key resource in driving verification and validation activities: be responsible for ensuring design documentation is clear and complete for hand off to Verification Engineering; be a coach and mentor in developing formal test methods to support the V&V team; articulate testing challenges and needs early in the system life cycle to drive cross-functional engagement
Other duties as assigned

Qualification

Medical device developmentRequirements developmentFDA-regulated environmentsSoftware development processesDesign control processesCollaboration skills

Required

Familiarity with medical device product development life cycles
Working knowledge of software development processes
Understanding of requirements development, testing, and traceability within a system development life cycle
Ability to work within FDA-regulated environments and follow internal SOPs
Basic knowledge of design control processes
Strong collaboration skills and ability to work effectively within cross-functional teams
Undergraduate degree in an engineering discipline
2-5 years of experience in product development, medical device engineering, or related field

Preferred

Graduate degree preferred
At least 1-2 years supporting systems engineering activities or working in FDA/GMP-regulated environments preferred

Company

ATEC Spine

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ATEC Spine is a medical device company dedicated to revolutionizing the approach to spine surgery through innovation.

H1B Sponsorship

ATEC Spine has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (5)
2023 (5)
2022 (2)
2021 (3)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$1.02B
Key Investors
Squadron Medical Finance Solutions
2025-03-03Post Ipo Debt· $350M
2023-10-24Post Ipo Equity· $150M
2023-04-19Post Ipo Equity· $60M

Leadership Team

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Pat Miles
Chairman & CEO
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Craig Hunsaker
Executive Vice President, People & Culture
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Company data provided by crunchbase