Overview

Oracle Health is revolutionizing healthcare innovation, and we're seeking a Principal Member of Technical Staff to define and govern software architecture and compliance for regulated medical devices. Join us to improve patient outcomes on a global scale. This role drives cutting-edge solutions in a dynamic, high-impact environment.

Responsibilities

• Define and govern software architecture for regulated medical devices, ensuring scalability and performance.
• Establish and maintain compliance frameworks aligned with FDA, IEC 62304, and other regulatory standards.
• Lead cross-functional teams in designing secure, reliable medical device software systems.
• Conduct risk assessments and mitigation strategies for software in healthcare applications.
• Collaborate with product managers, engineers, and regulatory experts to align technical roadmap with business goals.
• Review and approve architectural designs, codebases, and deployment pipelines for compliance.
• Mentor senior engineers and advocate for best practices in medical device software development.
• Stay abreast of evolving regulations and industry standards to proactively adapt frameworks.

Qualifications

• 15+ years of experience in software engineering, with 8+ years in medical device or regulated industries.
• Deep expertise in software architecture for embedded systems, cloud, or hybrid medical environments.
• Proven track record with FDA 510(k), IEC 62304, ISO 13485, and cybersecurity standards (e.g., IEC 62366).
• Strong proficiency in Java, C++, or Python, with experience in agile methodologies.
• Excellent leadership and communication skills to influence at executive levels.
• Bachelor's or Master's in Computer Science, Software Engineering, or related field.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• 401(k) matching and employee stock purchase program.
• Flexible remote work options and generous PTO.
• Professional development stipend and wellness programs.