Remote Position
[Remote] Principal Technical Learning Consultant – SaMD Product Development & QA
🌍 Remote · United States
💼 Full-time
Note: The job is a remote job and is open to candidates in USA. Oracle is a technology company providing cloud, infrastructure, applications, and healthcare solutions. Oracle is seeking a Principal Technical Learning Consultant to design, deliver, and lead learning programs for regulated medical device software development. The role translates regulatory, quality, systems engineering, risk management, and product development concepts into practical learning experiences and supports compliance, competency, and execution quality across product development teams.
Responsibilities
- 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
- 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
- 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
Skills
- Applicants are required to read, write, and speak the following languages: English
- * 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
- * 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
Benefits
- May be eligible for bonus and equity.
- Medical, dental, and vision insurance, including expert medical opinion
- Short term disability and long term disability
- Life insurance and AD&D
- Supplemental life insurance (Employee/Spouse/Child)
- Health care and dependent care Flexible Spending Accounts
- Pre-tax commuter and parking benefits
- 401(k) Savings and Investment Plan with company match
- 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.
- 11 paid holidays
- 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.
- Paid parental leave
- Adoption assistance
- Employee Stock Purchase Plan
- Financial planning and group legal
- Voluntary benefits including auto, homeowner and pet insurance
- Flexible medical, life insurance, and retirement options
- Volunteer programs
Company Overview