Principal Technical Learning Consultant – SaMD Product Development & QA
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.
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.
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.
Qualifications --------------
Disclaimer:
Certain U.S. based or U.S. customer or client-facing roles may be required to comply with applicable requirements, such as immunization/occupational health mandates, and/or drug testing requirements.
Range and benefit information provided in this posting are specific to the stated locations only
US: Hiring Range in USD from: $91,400 to $187,000 per annum. May be eligible for bonus and equity.
Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.
Oracle US offers a comprehensive benefits package which includes the following: 1. Medical, dental, and vision insurance, including expert medical opinion 2. Short term disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation. 9. 11 paid holidays 10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. Voluntary benefits including auto, homeowner and pet insurance
The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.
Career Level - IC4
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