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Added 1 min ago
G
Civil Professional Engineer (PE)
GPAC
Houston, TX
- $100,000 to $130,000 USD / year
We are seeking a licensed Civil Professional Engineer (PE) to join our growing civil engineering division of our multi-disciplinary firm. The successful candidate will lead the design and…
Added 1 min ago
School Nutrition Talent Development Coordinator,
Charlotte-Mecklenburg Schools
Charlotte, NC
Ability to learn and use specialized tools, equipment or software related to business needs
Added 8 mins ago
Rendezvous and Proximity Operations Oversight Software Engineer
Amentum
Houston, TX
…NASA’s pursuits in deep space exploration. As NASA’s largest engineering solutions provider working together with NASA at centers across the United…
Added 14 mins ago
Vanguard-IP
Vanguard-IP
Washington, DC, DC
…technologies, communication networks, electrical hardware and software, computer networks, semiconductors, storage devices, circuits, memory, cloud computing, data security, or wearable…
Added 19 mins ago
Estimator II
Mortenson Company
Seattle, WA
Support lead estimator in data input into estimating software program(s)
Added 26 mins ago
A&
Systems Engineer - Federal
Astor & Sanders
Remote, United States
- $120,000 to $160,000 USD / year
Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related field.
Added 26 mins ago
A&
Senior Project Manager
Astor & Sanders
McLean, VA
- $120,000 to $145,000 USD / year
Bachelor's degree in a relevant field such as business, information technology, or engineering.
Added 26 mins ago
G
Commercial Flooring Estimator
GPAC
Dover, DE
- $80,000 to $120,000 USD / year
Assist the sales and project-management teams with budgets, value engineering, and change-order pricing.
Added 26 mins ago
Project Manager - Marine Construction
Orion
Metairie, LA
Interprets project drawings, specifications, contracts, and engineering documents for project teams, clients, and vendors.
Added 26 mins ago
Senior Project Manager - Marine Construction
Orion
Federal Way, WA
BS Degree in Civil Engineering/Construction Management, and 8 years’ experience, or related discipline, or equivalent work experience, is required. For degreed candidates, prior work…
Added 26 mins ago
O
Project Manager - Marine Construction
Orion
Federal Way, WA
- $150,000 to $175,000 USD / year
…Materials, Procurement, Estimating, Scheduling, Project Tracking Software, Cost Control, Engineering & Project…
Added 26 mins ago
Assistant Project Manager - Marine Construction
Orion
Federal Way, WA
…Materials Procurement, Estimating, Scheduling, Project Tracking Software, Cost Control, Engineering & Project Standards, and Safety & Environmental…
Added 26 mins ago
O
Field Engineer
Orion
Federal Way, WA
- $75,000 to $95,000 USD / year
…Materials Procurement, Estimating, Scheduling, Project Tracking Software, Cost Control, Engineering & Project Standards, and Safety & Environmental…
Added 26 mins ago
Project Manager - Marine Construction
Orion
Vancouver, WA
A B.S. Degree in Civil Engineering/Construction Management or related discipline and a minimum of 8 years' experience is required. Prior work experience in the marine construction or heavy…
Added 26 mins ago
Estimator - Marine Construction
Orion
Federal Way, WA
…Procurement, Construction Estimating, Scheduling, Project Tracking Software, Cost Control, Project Standards, and Safety & Environmental Compliance. B.S. in Civil Engineering/Construction…
Added 26 mins ago
Field Engineer - Marine Construction
Orion
Honolulu, HI
A B.S. Degree in Civil Engineering/Construction Science or related discipline or equivalent work experience is required. Prior hands-on work experience in the marine construction industry…
Added 26 mins ago
Project Engineer - Marine Construction
Orion
Honolulu, HI
BS Degree in Civil Engineering/Construction Science or related discipline and 2 years of work experience is required. The incumbent must have a working knowledge of Project Management &…
Added 26 mins ago
O
Project Executive - Marine Construction
Orion
Federal Way, WA
- $190,000 to $260,000 USD / year
Partner with the Regional Vice President, Area Manager, Operations, Business Development, Estimating, Equipment, and Engineering teams to execute regional business objectives.
Added 26 mins ago
Senior Project Engineer
Orion
Houston, TX
The Senior Project Engineer – Marine Construction provides project engineering and field support for Orion's marine and heavy civil construction projects.
Added 26 mins ago
O
Project Manager - Marine Construction
Orion
Honolulu, HI
- $170,000 to $190,000 USD / year
A B.S. Degree in Civil Engineering, Construction Management, or a related discipline and a minimum of eight (8) years of construction experience is required.
Added 26 mins ago
O
Sr. Project Manager - Marine Construction
Orion
Honolulu, HI
- $180,000 to $250,000 USD / year
…Methods, Procurement, Estimating, Scheduling, Project Tracking Software, Cost Control, Engineering and Project Standards, and Safety and Environmental…
Added 26 mins ago
O
Estimator - Marine Construction
Orion
Honolulu, HI
- $130,000 to $170,000 USD / year
…Estimator works closely with Project Management, Operations, Engineering, subcontractors, suppliers, and other members of the project team to support successful project pursuits from…
Added 26 mins ago
Project Manager - Marine Dredging
Orion
Vancouver, WA
Added 26 mins ago
Structural Engineer
Orion
Houston, TX
Utilizes structural analysis and design software to perform engineering calculations and evaluate structural systems.
Added 27 mins ago
Field Engineer
Orion
Houston, TX
A B.S. Degree in Civil Engineering/Construction Science or related discipline or equivalent work experience is required. Prior hands-on work experience in the marine construction industry…

Oracle

Principal Technical Learning Consultant - 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, safety, cyb...

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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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