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Added 6 mins ago
Senior Contract Manager, Enterprise Accounts - Minneapolis, MN
Medtronic
Lafayette, CO
Experience with enterprise accounts, health systems, Group Purchasing Organizations (GPOs), or Integrated Delivery Networks (IDNs).
Added 6 mins ago
M
US - Electrical Engineer - G00546
ManpowerGroup
Arvada, CO
- Up to $150 USD / hour
Our client, a leading aerospace and defense technology organization, is seeking a Electrical Engineer to join their team. As an Electrical Controls Engineer, you will be part of the…
Added 6 mins ago
Group Product Manager, Data Center Software and Operations
Google
Sunnyvale, CA
…within networking, storage, compute hardware, databases, file systems, data analytics, cluster management, and other software infrastructure…
Added 6 mins ago
Staff Software Engineer, Infrastructure
Google
Sunnyvale, CA
5 years of experience with software design and architecture across distributed systems, developer platforms/tooling, container/virtualization runtimes, or AI/cloud infrastructure.
Added 6 mins ago
Senior Controls & SCADA Engineer - Data Centers Job Details | Black & Veatch Family of Companies
Black & Veatch
Greenwood Village, CO
Senior Controls & SCADA Engineer - Data Centers
Added 7 mins ago
Controls & SCADA Engineer - Data Centers Job Details | Black & Veatch Family of Companies
Black & Veatch
Greenwood Village, CO
…engineering, SCADA integration, grid automation, and energy management systems. This role will support the design and execution of first-of-a-kind (FOAK) projects involving complex control…
Added 7 mins ago
PT
Flight Sciences Engineer
PDS Tech Commercial
Englewood, CO
- $60.02 USD / hour
…PDS Tech Commercial is seeking an experienced Flight Sciences Engineer to join a cutting-edge aerospace team developing advanced aircraft and aerospace…
Added 7 mins ago
Enterprise Account Project Coordinator III (Remote, USA)
Medtronic
Boulder, CO
Experience using Salesforce.com or other customer relationship management systems.
Added 7 mins ago
Engineering Project/Program Manager
Trimble Inc.
Boulder, CO
Empower Machine Automation and Precision: Shape the Future as our Next Proactive Quality Engineer! Ready to make a tangible impact on global construction and mining industries using…
Added 7 mins ago
Mechanical Field Engineer, IAD North Field Engineering
Amazon Data Services, Inc.
Herndon, VA
As an Amazon Critical Infrastructure Engineer, you will provide full life-cycle support to AWS Data Centers from design inception through site improvement and maintenance. You will be the…
Added 7 mins ago
Critical Infrastructure Senior Mechanical Engineer- Data Center and Rack Testing Facility, Field Engineering
Amazon Data Services, Inc.
Florence, KY
…logistics of rack hardware before deployment to data centers. The engineer will support the facility's cooling infrastructure (not the IT equipment itself), ensuring the physical…
Added 7 mins ago
Sr. Satellite Test Engineer
Lockheed Martin
Littleton, CO
Lockheed Martin is seeking a Senior Level Electrical System Integration/Test Engineer to join the GPS integration and test team within Assembly, Test, and Launch Operations (ATLO). In this…
Added 7 mins ago
Sr Satellite Test Engineer
Lockheed Martin
Littleton, CO
Lockheed Martin is seeking a Senior Level Electrical System Integration/Test Engineer to join the GPS integration and test team within Assembly, Test, and Launch Operations (ATLO). In this…
Added 7 mins ago
Software Engineer Stf.
Lockheed Martin
Littleton, CO
At Lockheed Martin Rotary and Mission Systems (RMS), we are driven by innovation and integrity. We believe that by applying the highest standards of business ethics and visionary thinking,…
Added 7 mins ago
Principal Systems Engineer – Network Sys Engr III (26-388)
Northrop Grumman
Colorado Springs, CO
Northrop Grumman Space Systems - Missile Defense Integration offers an excellent opportunity for a Principal Engineer Systems – Network Sys Engr III (26-388) to join our team of skilled and…
Added 7 mins ago
Staff Integration & Test Engineer (SME) (26-424)
Northrop Grumman
Colorado Springs, CO
Northrop Grumman Space Systems - Missile Defense Integration offers an excellent opportunity for a Staff Integration & Test Engineer (SME) (26-424) to join our team of skilled and diverse…
Added 7 mins ago
INTERNAL ONLY: Principal Software Engineer (26-434)
Northrop Grumman
Colorado Springs, CO
Northrop Grumman Space Systems - Missile Defense Integration offers an excellent opportunity for a Principal Software Engineer (26-434) to join our team of skilled and diverse…
Added 7 mins ago
Orbital Warfare Test Range Engineer
The Aerospace Corpor
Colorado Springs, CO
…innovative solutions that span satellite, launch, ground, and cyber systems for defense, civil and commercial customers. When you join our team, you'll be part of a special collection of…
Added 7 mins ago
Principal Engineer Software III (26-404)
Northrop Grumman
Colorado Springs, CO
Northrop Grumman Space Systems - Missile Defense Integration offers an excellent opportunity for a Principal Engineer Software III (26-404) to join our team of skilled and diverse…
Added 7 mins ago
Cyberspace Warfare Force Development Senior Project Engineer
The Aerospace Corpor
Colorado Springs, CO
…innovative solutions that span satellite, launch, ground, and cyber systems for defense, civil and commercial customers. When you join our team, you'll be part of a special collection of…
Added 7 mins ago
Senior Security GRC Engineer, AI & Automation
American Express Global Business Travel
Denver, CO
Bachelor’s degree in computer science, information security, information systems, or a related field (or equivalent experience).
Added 7 mins ago
Associate Software Engineer
Highmark Health
Denver, CO
This job is an integral member of an agile software engineer team responsible for building scalable software applications across all digital channels to serve our customers. Responsible for…
Added 7 mins ago
Network Operations Engineer
Meta
Denver, CO
Meta is seeking a Network Operations Engineer to join our Edge and Network Services (ENS) Foundation NetOps team. In this role, you will utilize your knowledge in hyperscale data center…
Added 7 mins ago
Sr. Controls Engineer, Data Center, Colocation Regional Engineering - AMER
Amazon
Denver, CO
As a Controls Colo Engineer, you will work with internal business teams and with colocation vendors to identify, document, and resolve any operational/design deficiencies which could impact…
Added 7 mins ago
Traveling Aptitude Senior Project Engineer- Cheyenne
J.E. Dunn Construction Company
Denver, CO
The Senior Project Engineer will manage a small project or a component of a large or more complex project with oversight. This position will fully apply JE Dunn processes and tools to…

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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