Systems Engineer II

Alphatec Spine•Louisville, CO

About The Position

The Systems Engineer II supports the design, development, and integration of surgical Navigation and Robotics systems under the guidance of senior systems and project leadership. This role contributes across the system life cycle, including requirements development, system characterization, testing, verification support, and design transfer activities. The Systems Engineer II works cross-functionally with mechanical and software engineering teams, as well as quality, regulatory, marketing, and operations, to ensure system requirements are clearly defined, implemented, and verified.

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.
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, graduate degree preferred.
2–5 years of experience in product development, medical device engineering, or related field.
At least 1–2 years supporting systems engineering activities or working in FDA/GMP-regulated environments preferred.
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).

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.