Principal Technical Curriculum Developer – SaMD Product Development & QA

Ll Oefentherapie; United States; On-site; USD 140,000 - 210,000; Full time

Job summary

Oracle Health is seeking a Principal Technical Learning Consultant to design, build, and lead learning programs that enable teams to develop safe, compliant, and effective medical device software. This role translates regulatory, quality, systems engineering, risk management, and product development concepts into practical, role-based experiences for engineers, product managers, TPMs, and leaders.

The role supports more than 10,000 product development professionals across Oracle Health and

Qualifications

• Experience designing regulatory training for medical device software.
• Ability to translate complex regulatory concepts into practical learning.
• Strong collaboration with engineering, product, quality and regulatory teams.

Responsibilities

• Design and deliver instructor-led, workshop-based, virtual and self-paced learning programs for regulated product development teams.
• Create onboarding, role-based learning paths, workshops, certifications and continuous education programs.
• Develop scalable learning strategies to improve competency, compliance and execution quality.
• Partner with leadership to identify capability gaps and organizational priorities for training.

Job description

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.