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Added 24 mins ago
Data Engineer/Architect
Leidos
Remote, United States
Leidos has an exciting opportunity for an experienced Data Engineer/Architect to support the design of a new data foundation. This foundation will support generative AI applications,…
Added 24 mins ago
Lead Director Product Membership
CVS Health
Remote, United States
Reporting directly to the Executive Director, Digital Product – Patient Growth & Engagement , you will serve as the dedicated domain engineering and product leader responsible for driving…
Added 25 mins ago
ENGINEER SOFTWARE 1
Huntington Ingalls Industries
Newport News, VA
Designs, develops, documents, tests and debugs applications software and systems that contain logical and mathematical solutions. Conducts multidisciplinary research and collaborates with…
Added 25 mins ago
SAP NS2 Senior Cloud Security Engineer-TS/SCI poly Onsite - Chantilly, VA
SAP
Herndon, VA
SAP is the global market leader for business software and related services. SAP National Security Services Inc.® (SAP NS2®) is an independent U.S. subsidiary of SAP. At SAP NS2, we leverage…
Added 25 mins ago
Software Engineering Lead and Application Architect - TS/SCI with Polygraph
General Dynamics Information Technology
Chantilly, VA
We are seeking a Lead Engineer to drive the end-to-end software engineering function for mission and enterprise applications across classified environments. This role is accountable for…
Added 25 mins ago
Front-end Engineer 4 (Manager, IC)
Capital One
McLean, VA
…owning full-feature architecture end-to-end. As a Front End Engineer on our Cars and Ground Transportation team, you'll join a fast-moving, product-driven group of makers, doers, and…
Added 25 mins ago
G
Technical Lead, Full-Stack Engineering – AI-Native Solutions
Guidehouse
MCLEAN, VA
- $113,000 to $188,000 USD / year
Build, test, deploy, and maintain secure, scalable full-stack enterprise software within Guidehouse’s Chief Transformation Officer (CXO) organization, supporting AI Transformation, Solution…
Added 25 mins ago
G
Full-Stack Engineer – AI-Native Solutions
Guidehouse
MCLEAN, VA
- $98,000 to $163,000 USD / year
Build, test, deploy, and maintain secure, scalable full-stack enterprise software within Guidehouse’s Chief Transformation Officer (CXO) organization, supporting AI Transformation, Solution…
Added 25 mins ago
Lead AI Software Engineer
Wells Fargo
MCLEAN, VA
As an AI Engineer, you will build user-facing applications and backend services that integrate with Model Context Protocol (MCP) servers, LLM-based applications, RAG-based retrieval…
Added 25 mins ago
Senior AI Software Engineer
Wells Fargo
MCLEAN, VA
As an AI Engineer, you will build user-facing applications and backend services that integrate with Model Context Protocol (MCP) servers, LLM-based applications, RAG-based retrieval…
Added 25 mins ago
Data Engineer, Analytics (Technical Leadership)
Meta
Richmond, VA
Build cross-functional relationships with Data Scientists, Product Managers and Software Engineers to understand data needs and deliver on those needs
Added 25 mins ago
DevOps Engineer III
Deloitte
Rosslyn, VA · Richmond, VA · McLean, VA
…and operational improvement to help organizations strengthen software delivery performance and business…
Added 25 mins ago
Software Engineer, Machine Learning RecSys
Meta
Richmond, VA
Software Engineer, Machine Learning RecSys Responsibilities:
Added 25 mins ago
AT
Senior Software Engineer
Akamai Technologies, Inc.
Richmond, VA
- $121,400 to $218,600 USD / year
As a Software Engineer Senior, you will be responsible for:
Added 25 mins ago
C
AI Data Engineer
Cognizant
Richmond, VA
- $100,000 to $115,000 USD / year
As an AI Data Engineer, you will make an impact by designing, building, and optimizing scalable cloud-native data engineering solutions that enable advanced AI-driven applications and…
Added 25 mins ago
C
AI Data Engineer
Cognizant
Richmond, VA
- $100,000 to $115,000 USD / year
As an AI Data Engineer, you will make an impact by designing, building, and optimizing scalable cloud-native data engineering solutions that enable advanced AI-driven applications and…
Added 25 mins ago
Staff Software Architect
CVS Health
Richmond, VA
We are looking for a Staff Software Architect to serve as a technical leader within the Clinical Insights Engine team at CVS Health. This is a senior individual contributor role with…
Added 25 mins ago
Lead AI and Data Science Engineer II- Marketing Measurement
Deloitte
McLean, VA · Rosslyn, VA · Richmond, VA
…collaborative environment? As an experienced Lead AI and Data Science Engineer II - Marketing Measurement, you will have the opportunity to share new ideas and collaborate on projects as a…
Added 25 mins ago
C
Java Full Stack Engineer with Spring boot/AWS Experience
Cognizant
Richmond, VA
- $86,000 to $99,000 USD / year
As a Java Full Stack Engineer with Spring boot/AWS exp, you will make an impact by designing and delivering scalable, cloud-native healthcare payer applications that improve payment…
Added 26 mins ago
EG
Cloud Engineer
Eliassen Group
Richmond, VA
- $70 to $88 USD / hour
Our client seeks a senior Cloud Engineer to own and stabilize a legacy GCP and Azure footprint while assisting with conversions and decommissioning. The role will support automation efforts…
Added 1 hour ago
P
Member of Technical Staff (Software Engineer, AI Policy and Strategic Initiatives)
Perplexity
San Francisco, CA · Washington, DC
- $220,000 to $405,000 USD / year
- Embed with our People team to implement first-party software solutions for recruiting, labor compliance, and performance management.
Added 2 hours ago
Senior Software Engineer, Network Platform Security
Cisco
Milpitas, CA
Join the Infrastructure Engineering team as a Software Engineer and help redefine how networking problems are solved. You will develop innovative software for next-generation networking…
Added 2 hours ago
EG
Cloud Engineer
Eliassen Group
Hartford, CT
- $70 to $88 USD / hour
Our client seeks a senior Cloud Engineer to own and stabilize a legacy GCP and Azure footprint while assisting with conversions and decommissioning. The role will support automation efforts…
Added 3 hours ago
IT Product Developer II, III, IV
Williams Companies
Tulsa, OK
A s a Product Engineer at Williams, you will play a critical role in designing and delivering in ‑ house software products that directly support our business. This role goes beyond…
Added 3 hours ago
IT Product Developer II, III, IV
Williams Companies
Tulsa, OK
As a Product Engineer at Williams, you will play a critical role in designing and delivering in‑house software products that directly support our business. This role goes beyond traditional…

Oracle

Principal Technical Curriculum Developer - SaMD Product Development & QA

Jefferson City, MO, United States

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Job details

Posting language: English

Original job description

Summary

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.

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, safet...

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More about this job

Skills

Curriculum development
Risk management
Oracle
Onboarding
Regulatory compliance
Medical devices
Documentation
Regulatory affairs
Cybersecurity
Quality assurance procedures
Usability engineering
Computer science
Program management
Software development
Quality control systems
Communication skills
Presentation skills
Inspection
Teaching
Coaching
Adult education
Learning technologies
Software anomalies

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