Principal Technical Learning Consultant – SaMD Product Development & QA
Oracle · United States
We are seeking a highly experienced Principal Technical Learning Consultant to help design, build, and lead the next generation of learning programs that enable teams to develop safe, compliant, and effective medical device software.
This is not a traditional training or curriculum development role.
We are looking for someone who understands how regulated healthcare software is actually developed and can translate complex regulatory, quality, systems engineering, risk management, and product development concepts into practical, role-based learning experiences for engineers, product managers, TPMs, systems engineers, quality professionals, and development leaders.
This role will play a critical part in establishing an embedded learning function supporting more than 10,000 product development professionals across Oracle Health.
What You'll Do
Build Product Development Learning Programs
- Design and deliver instructor-led, workshop-based, virtual, and self-paced learning programs supporting Oracle Health's regulated product development organizations.
- Create onboarding, role-based learning paths, technical workshops, certifications, and continuous education programs.
- Develop scalable learning strategies that improve competency, productivity, compliance, and execution quality.
- Conduct learning needs assessments and partner with leadership to identify capability gaps and organizational priorities.
Teach Teams How to Build Regulated Medical Devices
Develop and deliver learning experiences focused on:
- Software as a Medical Device (SaMD)
- Medical Device Development Lifecycle
- Design Controls
- Requirements Engineering
- Systems Engineering
- Traceability Management
- Risk Management
- Hazard Analysis
- FMEA
- Fault Tree Analysis
- HAZOP
- Verification & Validation
- Software Anomaly Management
- Change Control
- Technical File Creation & Maintenance
- Submission Readiness
- Audit Readiness
- Regulatory Documentation
- AI Governance and Responsible AI Development
- Product Development Processes and Tooling
Partner Across Product Development
- Work closely with Engineering, Product Management, Quality, Regulatory Affairs, Clinical Safety, Cybersecurity, Human Factors, TPMs, and Compliance teams.
- Collaborate with subject matter experts to transform complex technical knowledge into practical learning experiences.
- Support adoption of new tools, processes, standards, and methodologies across development organizations.
- Build learning content that enables teams to effectively perform regulated development activities within Oracle's Quality Management System.
Support SaMD and Regulatory Excellence
Help teams understand how to operationalize and comply with:
- IEC 62304 – Medical Device Software Lifecycle Processes
- IEC 82304 – Healthcare Software Safety and Security
- ISO 13485 – Medical Device Quality Management Systems
- ISO 14971 – Risk Management for Medical Devices
- IEC 62366 – Usability Engineering
- IEC 81001-5-1 – Cybersecurity for Health Software
- ISO/IEC 27001 – Information Security
- ISO/IEC 42001 – AI Management Systems
- FDA Software Guidance
- EU MDR / IVDR
- IMDRF SaMD Frameworks
Develop Modern Learning Solutions
- Create instructor-led training, workshops, simulations, labs, job aids, videos, eLearning modules, process guides, and certification programs.
- Develop case studies, real-world scenarios, and hands-on exercises that help teams apply learning directly to their day-to-day work.
- Measure learning effectiveness through assessments, feedback, business outcomes, and adoption metrics.
- Continuously improve learning content based on learner feedback, audit findings, process improvements, and organizational priorities.
Only Oracle brings together the data, infrastructure, applications, and expertise to power everything from industry innovations to life-saving care. And with AI embedded across our products and services, we help customers turn that promise into a better future for all. Discover your potential at a company leading the way in AI and cloud solutions that impact billions of lives.
True innovation starts when everyone is empowered to contribute. That’s why we’re committed to growing a workforce that promotes opportunities for all with competitive benefits that support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.
We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_mb@oracle.com or by calling 1-888-404-2494 in the United States.
Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
Oracle Health Applications & Infrastructure (OHAI) is modernizing the future of healthcare through intelligent, cloud-native platforms that power clinical and operational workflows at global scale. As Oracle Health expands its portfolio of regulated healthcare technologies and Software as a Medical Device (SaMD) solutions, we are establishing a new embedded Product Development Learning organization focused on building world-class capabilities across engineering, product, quality, regulatory, and program management teams.