Staff Software Engineer

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JOB SUMMARY

The Staff Software Engineer is a senior-level technical leader responsible for shaping the long-term architecture and implementation strategy for the company’s medical device software platform. This role requires deep expertise across all layers of the technology stack and hands-on involvement in software design, implementation, and delivery. The Staff Software Engineer serves as a subject matter expert, mentoring senior engineers, driving cross-team initiatives, and collaborating with clinical and regulatory leaders to build robust and scalable solutions for surgical guidance and planning.

DUTIES AND RESPONSIBILITIES

  1. Design and implement high-performance, production-grade software in C# and C++ across key components of the system, including imaging, user interfaces, and data processing pipelines.
  2. Own and evolve the long-term architecture of the surgical navigation and planning system, ensuring scalability, modularity, and regulatory compliance.
  3. Provide direction and support to engineering team, aligning design decisions and priorities across projects.
  4. Lead technical evaluations, R&D efforts, and drive adoption of emerging technologies (e.g., AI-based segmentation, 3D visualization, AR integration).
  5. Guide and review system-level design documents and critical code components to ensure performance, security, and maintainability.
  6. Mentor Principal, Senior, and mid-level engineers, fostering technical growth and encouraging engineering excellence.
  7. Champion continuous improvement in development workflows, code quality standards, and software life cycle practices across the organization.
  8. Partner with clinical advisors, regulatory specialists, and product stakeholders to define system requirements and ensure compliance with FDA and ISO standards.
  9. Lead design reviews, perform risk assessments, and support verification and validation activities aligned with ISO 14971 and IEC 62304.

EXPERIENCE AND QUALIFICATIONS

  • Education: Master’s degree in Computer Science or related field with 10+ years of software development experience, or Bachelor’s degree with 14+ years.
  • Technical Mastery:
    • Deep domain experience in medical image processing, computational geometry, 3D visualization, and/or surgical workflow modeling.
    • Strong, current expertise in both C# and C++, with experience in .NET development environments and system design.
    • Demonstrated leadership in designing, implementing, and scaling complex software systems in safety-critical or regulated domains.
  • Systems Thinking: Ability to decompose large, ambiguous problems and deliver aligned, modular, and reusable solutions.
  • Regulatory Knowledge: Deep familiarity with FDA Class II/III medical device software requirements and standards such as ISO 13485, IEC 62304, and ISO 14971.
  • Agile & Tooling Experience: Demonstrated experience leading teams in Agile development methodologies and utilizing software development lifecycle (SDLC) tools (e.g., Jira, Git, CI/CD systems, static analysis tools).
  • Collaboration: Strong communication skills and a proven track record of cross-functional work with clinicians, quality, and engineering peers.
  • Leadership: Experience mentoring senior-level engineers, influencing architecture, and driving organization-wide technical decisions.