Principal Software Engineer

**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