Principal Technical Curriculum Developer - SaMD Product Development & QA

TrulyHired; United States; On-site; USD 140,000 - 200,000; Full time

Job summary

TrulyHired is seeking a Principal Technical Curriculum Developer to lead learning programs for SaMD product development and QA. You will translate regulatory, quality, and systems engineering concepts into practical, role-based training for engineers, product managers, TPMs, and leadership.

The role focuses on establishing an embedded learning function supporting thousands of product development professionals and collaborating with regulatory and quality teams to ensure compliant, effective

Qualifications

• Bachelor's degree in a relevant 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 in regulated industries, preferably healthcare, medical device, or SaMD environments.
• Strong understanding of software development lifecycle processes.
• Direct experience with requirements engineering, risk management, hazard analysis, traceability, verification and validation, technical documentation, design controls, quality systems.

Responsibilities

• Design and deliver learning programs for regulated product development teams across Oracle Health.
• Create onboarding, role-based learning paths, technical workshops, certifications, and continuous education programs.
• Develop scalable learning strategies to improve competency, productivity, compliance, and execution quality.
• Partner with leadership to identify capability gaps and organizational priorities; translate complex regulatory concepts into practical training.

Skills

Regulated healthcare software

Quality engineering

Systems engineering

Regulatory affairs

Technical program management

Instructional design

Adult learning principles

Education

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

Job description

Principal Technical Curriculum Developer - SaMD Product Development & QA Full Description

Principal Technical Curriculum Developer - SaMD Product Development & QA

United States

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

• 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.

Responsibilities

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.