Principal Software Engineer

Draper, UT

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

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