Principal Software Engineer

X

Xenter

Principal Software Engineer

Draper, UT
Full Time
Paid
  • Responsibilities

    **Overview:
    **

    ****Xenter is a technology in medicine company that is bringing medical devices to the digital age. Xenter is revolutionizing medicine by developing and launching smart/wireless guidewires and catheters that transmit data through a proprietary wireless network to our proprietary cloud that houses real-time Physical Intelligence medical data.

    We are seeking an experienced Principal Software Engineer to lead the design, development, and scaling of enterprise-level software solutions in the medical technology field.

    This role requires a unique combination of technical expertise, leadership skills, and regulatory knowledge to drive innovation while ensuring compliance with FDA standards.

    Essential Requirements:

    Technical Skills

    • Frontend/Backend Development: Proficiency in .NET, React, and TypeScript
    • Enterprise Scaling: Proven experience scaling software applications for large enterprise environments
    • Software Architecture: Deep understanding of scalable, maintainable software design patterns
    • Database Management: Experience with relational and NoSQL databases
    • DevOps & CI/CD: Knowledge of deployment pipelines, containerization, and cloud infrastructure

    Leadership & Collaboration

    • People Skills: Exceptional interpersonal and communication abilities to work effectively across departments(Engineering, QA, Regulatory, Clinical, Product Management)Team Leadership: Experience leading and mentoring engineering teams of 5+ developers
    • Project Management: Strong project management skills with experience in Agile/Scrum methodologies
    • Cross-functional Leadership: Ability to influence and drive technical decisions across multiple teams

    Professional Experience

    • 8+ years of software engineering experience with at least 3 years in a senior/principal role
    • 5+ years experience with .NET framework and modern web technologies
    • 3+ years experience with React and TypeScript in production environments

    Preferred Requirements:

    ** Regulatory & Industry Experience**

    • FDA 510(k) Submissions: Direct experience with FDA software submissions, particularly 510(k) processes
    • Medical Device Software: Understanding of IEC 62304 (Medical Device Software Life Cycle Processes)
    • Quality Management Systems: Familiarity with ISO 13485 and FDA Quality System Regulation (QSR)
    • Validation & Verification: Experience with software V&V processes in regulated environments

    Advanced Technical Skills

    • AI/Machine Learning: Understanding of AI technologies, model integration, and MLOps
    • Cloud Platforms: Experience with Kubernetes and high availability
    • Microservices Architecture: Experience designing and implementing microservices at scale
    • Security: Knowledge of healthcare data security standards (HIPAA, GDPR) and secure coding practices
    • API Design: RESTful API design and Postgres experience

    Additional Qualifications

    • Healthcare Domain: Experience in healthcare, medical devices, or life sciences
    • Regulatory Software: Experience with software as a medical device (SaMD) classification
    • Performance Optimization: Experience with high-availability systems and performance tuning
    • Mentoring: Track record of developing junior and mid-level engineers

    Key Responsibilities:

    Technical Skills

    • Frontend/Backend Development: Proficiency in .NET, React, and TypeScript
    • Enterprise Scaling: Proven experience scaling software applications for large enterprise environments
    • Software Architecture: Deep understanding of scalable, maintainable software design patterns
    • Database Management: Experience with relational and NoSQL databases
    • DevOps & CI/CD: Knowledge of deployment pipelines, containerization, and cloud infrastructure

    Leadership & Collaboration

    • People Skills: Exceptional interpersonal and communication abilities to work effectively across departments(Engineering, QA, Regulatory, Clinical, Product Management)
    • Team Leadership: Experience leading and mentoring engineering teams of 5+ developers
    • Project Management: Strong project management skills with experience in Agile/Scrum methodologies
    • Cross-functional Leadership: Ability to influence and drive technical decisions across multiple teams

    Professional Experience

    • 8+ years of software engineering experience with at least 3 years in a senior/principal role
    • 5+ years experience with .NET framework and modern web technologies
    • 3+ years experience with React and TypeScript in production environments

    Regulatory & Industry Experience

    • FDA 510(k) Submissions: Direct experience with FDA software submissions, particularly 510(k) processes
    • Medical Device Software: Understanding of IEC 62304 (Medical Device Software Life Cycle Processes)
    • Quality Management Systems: Familiarity with ISO 13485 and FDA Quality System Regulation (QSR)
    • Validation & Verification: Experience with software V&V processes in regulated environments

    Advanced Technical Skills

    • AI/Machine Learning: Understanding of AI technologies, model integration, and MLOps
    • Cloud Platforms: Experience with Kubernetes and high availability
    • Microservices Architecture: Experience designing and implementing microservices at scale
    • Security: Knowledge of healthcare data security standards (HIPAA, GDPR) and secure coding practices
    • API Design: RESTful API design and Postgres experience

    Additional Qualifications

    • Healthcare Domain: Experience in healthcare, medical devices, or life sciences
    • Regulatory Software: Experience with software as a medical device (SaMD) classification
    • Performance Optimization: Experience with high-availability systems and performance tuning
    • Mentoring: Track record of developing junior and mid-level engineers

    Technical Leadership

    • Architect and design scalable software solutions for enterprise medical technology products
    • Lead technical decision-making for complex software projects
    • Establish coding standards, best practices, and development processes
    • Conduct technical reviews and ensure code quality across teams

    Project & People Management

    • Lead cross-functional project teams from conception to delivery
    • Mentor and develop engineering team members
    • Implement Product Management to translate business requirements into technical solutions
    • Coordinate with QA, Regulatory, and Clinical teams to ensure compliance and quality

    Regulatory Compliance

    • Ensure software development practices align with FDA regulations and industry standards
    • Support FDA submissions and regulatory documentation
    • Implement software risk management processes
    • Maintain traceability between requirements, design, and testing

    Innovation & Strategy

    • Drive technical innovation while maintaining regulatory compliance
    • Evaluate and integrate new technologies, including AI/ML capabilities
    • Contribute to technical roadmap and strategic planning
    • Stay current with industry trends and emerging technologies

    Education:

    Bachelor’s Degree in Computer Science or equivalent education and experience