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Senior Systems Engineer at ATEC Spine | Carlsbad, California

ATEC SpineCarlsbad, California, United States
On-site Full-time $125K/yr - $140K/yr

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Experience Level

Senior

Qualifications

Candidates should possess a Bachelor’s Degree in Engineering or a related field, along with significant experience in systems engineering within the medical device sector. A proven track record of working with cross-functional teams and leading complex projects is essential. Strong analytical and problem-solving skills, along with excellent communication abilities, are vital for success in this role.

About the job

Join ATEC Spine as a Senior Systems Engineer, where you'll spearhead the design and development of cutting-edge surgical, navigation, and informatics platforms. In this pivotal role, you will oversee systems throughout their life cycles, from refining user needs to verifying and validating designs.

Collaboration is key! You will work closely with multi-disciplinary teams including mechanical, electrical, software, clinical, and quality/regulatory experts to ensure the creation of robust and compliant system architectures that deliver exceptional performance. Additionally, you will provide technical leadership and mentorship to junior engineers, fostering a culture of excellence in systems engineering.

Key Responsibilities

Systems Engineering Leadership

  • Direct the development, breakdown, and management of system and subsystem requirements following INCOSE best practices.
  • Establish system architecture, interfaces, and integration strategies for complex systems that encompass software, hardware, and mechanical components.
  • Conduct trade studies, risk analyses, and hazard assessments while supporting design control activities for regulated medical devices.
  • Act as the technical authority for system performance, usability, and clinical workflow in spine surgery contexts.
  • Assist in compliance and product safety measures, including IEC 60601 evaluations and related certification testing.

Cross-Functional Collaboration

  • Engage with marketing, clinical, software, hardware, and quality/regulatory teams to refine user expectations and ensure smooth subsystem integration.
  • Lead cross-functional design reviews and provide analytical insights through modeling and systems-level analysis.
  • Partner with Quality and Regulatory teams to ensure traceability of requirements and preparation of submission-ready documentation (e.g., 510(k) inputs).
  • Create comprehensive design documentation for verification and validation efforts, engaging early to determine testing requirements.

Project & Technical Leadership

  • Guide and mentor junior engineers, reinforcing best practices in Systems Engineering.
  • Oversee major engineering projects as the primary systems owner, ensuring alignment with timelines, risk management, and business goals.
  • Maintain a strong presence in daily project execution to ensure structure and alignment across engineering teams.
  • Implement project management strategies to drive schedules, manage risks, and support program milestones.

About ATEC Spine

ATEC Spine is a pioneering organization dedicated to advancing the field of spine surgery through innovative technology and solutions. Our commitment to excellence and collaboration drives us to develop state-of-the-art products that enhance surgical outcomes and improve patient care.

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