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**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 #J-18808-Ljbffr