Principal Technical Learning Consultant – SaMD Product Development & Q

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.

Required Qualifications

Bachelor's degree in Engineering, Computer Science, Healthcare Technology, Regulatory Affairs, Quality, Education, Instructional Design, or related field.

8+ years of experience in medical device software, healthcare technology, quality engineering, systems engineering, regulatory affairs, product development, technical program management, or technical learning.

Experience working in regulated industries, preferably healthcare, medical device, or Software as a Medical Device (SaMD) environments.

Strong understanding of software development lifecycle processes.

Direct experience with one or more of the following:

Requirements engineering

Risk management

Hazard analysis

Traceability

Verification and validation

Technical documentation

Design controls

Quality systems

Exceptional communication, facilitation, and presentation skills.

Ability to influence highly technical audiences across multiple organizations.

Preferred Qualifications

Experience with IEC 62304, IEC 82304, ISO 13485, ISO 14971, IEC 62366, IEC 81001-5-1, or related healthcare regulations and standards.

Experience supporting regulatory submissions, audits, notified body reviews, or quality system inspections.

Experience building and maintaining Design History Files, Technical Files, risk management files, or regulatory evidence packages.

Experience teaching, coaching, onboarding, mentoring, or facilitating technical workshops.

Familiarity with cloud-native healthcare software development environments.

Experience supporting AI-enabled healthcare products and responsible AI development practices.

Experience developing learning content for engineers, TPMs, product managers, quality professionals, or technical teams.

Knowledge of adult learning principles, instructional design methodologies, and modern learning technologies.

Ideal Candidate Profile

The ideal candidate is a former Systems Engineer, Quality Engineer, Design Assurance Engineer, Regulatory Affairs Specialist, Technical Program Manager, Product Development Leader, Clinical Safety professional, or Medical Device Software Engineer who has a passion for helping others learn.

This individual understands not only what regulatory standards require, but how teams perform the actual work.

They can confidently stand in front of engineers, product managers, TPMs, quality leaders, and executives and teach:

How to create and maintain a compliant technical file.

How to perform hazard analysis and risk management activities.

How to establish traceability across the SDLC.

How to evaluate software anomalies from a patient safety perspective.

How to prepare evidence for audits and submissions.

How to build compliant AI-enabled healthcare products.

How to operationalize quality, safety, cybersecurity, and regulatory requirements within modern cloud-native software development environments.

Success in this role requires a unique combination of technical depth, systems thinking, regulatory knowledge, learning expertise, and organizational influence.