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Added 6 mins ago
G
Civil/Site Land Development PE/PM
GPAC
Tampa, FL
- $100,000 to $140,000 USD / year
Bachelors’ Degree in Civil Engineering from an ABET accredited program is required
Added 23 mins ago
Product Marketing Manager – Commercial Client
Advanced Micro Devices, Inc
Austin, TX
We are looking for a Product Marketing Manager to help bring our commercial products, technologies, and solutions to market. This role combines product marketing and program leadership,…
Added 28 mins ago
G
Civil/Site Land Development PE/PM
GPAC
Durham, NC
- $100,000 to $145,000 USD / year
Bachelors’ Degree in Civil Engineering from an ABET accredited program is required
Added 28 mins ago
Leadership Technical Program Manager II, Asset Reliability and Operations, Data Centers
Google
New York, NY · Council Bluffs, IA · Papillion, NE · New Albany, OH · The Dalles, OR · Sunnyvale, CA
…big picture in focus while being able to dive into the unique engineering challenges we face daily. As a Technical Program Manager at Google, you lead complex, multi-disciplinary…
Added 28 mins ago
G
Civil/Site Land Development PE/PM
GPAC
Raleigh, NC
- $100,000 to $145,000 USD / year
Bachelors’ Degree in Civil Engineering from an ABET accredited program is required
Added 34 mins ago
Vice President, Software Engineering
India: Mastercard Technology Private Limited
O'Fallon, MO
MasterCard is recruiting a Vice President of Software Engineering to lead software engineering teams developing advanced technologies and applications that are revolutionizing payments.…
Added 36 mins ago
Power & Hydrogen Solutions Technical Program Manager, Power & Hydrogen Solutions, GESA
Amazon.com Services LLC
Bellevue, WA
Amazon is seeking an experienced Technical Program Manager (TPM) to join our Global Engineering Services & Analytics (GESA) organization on the Power and Hydrogen Solutions team. In this…
Added 36 mins ago
G
Controls Engineer Manager
GPAC
Appleton, WI
- $105,000 to $135,000 USD / year
This is more than a controls engineering position. It is an opportunity to build, program, and commission custom equipment while gradually developing into the leader of the Controls…
Added 36 mins ago
G
Project manager Professional Engineer
GPAC
Jacksonville, FL
- $93,000 to $140,000 USD / year
Civil Engineer / Project Manager Opportunity with an Established Civil Engineering Firm
Added 37 mins ago
G
Project manager Professional Engineer
GPAC
Austin, TX
- $93,000 to $140,000 USD / year
Civil Engineer / Project Manager Opportunity with an Established Civil Engineering Firm
Added 37 mins ago
G
Project manager Professional Engineer
GPAC
Charlotte, NC
- $93,000 to $140,000 USD / year
Civil Engineer / Project Manager Opportunity with an Established Civil Engineering Firm
Added 37 mins ago
G
Project manager Professional Engineer
GPAC
Indianapolis, IN
- $93,000 to $140,000 USD / year
Civil Engineer / Project Manager Opportunity with an Established Civil Engineering Firm
Added 37 mins ago
G
Project manager Professional Engineer
GPAC
San Francisco, CA
- $93,000 to $140,000 USD / year
Civil Engineer / Project Manager Opportunity with an Established Civil Engineering Firm
Added 37 mins ago
G
Project manager Professional Engineer
GPAC
Seattle, WA
- $93,000 to $140,000 USD / year
Civil Engineer / Project Manager Opportunity with an Established Civil Engineering Firm
Added 37 mins ago
G
Project manager Professional Engineer
GPAC
Denver, CO
- $93,000 to $140,000 USD / year
Civil Engineer / Project Manager Opportunity with an Established Civil Engineering Firm
Added 37 mins ago
G
Project manager Professional Engineer
GPAC
Nashville, TN
- $93,000 to $140,000 USD / year
Civil Engineer / Project Manager Opportunity with an Established Civil Engineering Firm
Added 40 mins ago
J
Senior Product Manager - Estate Planning
Jobgether
Remote, United States
- $136,000 to $160,000 USD / year
…and next steps. Our partner is looking for a Senior Product Manager – Estate Planning based in the United…
Added 41 mins ago
CMMS Analyst
Cushman & Wakefield
Creve Coeur, MO
…cost-effective solutions, optimized operational processes, and extensive technical…
Added 44 mins ago
WV
Transportation Environmental Resources Program Manager 2 - Kanawha Co.
West Virginia
Charleston, WV
- $30.38 to $44.35 USD / hour
…Benefits (Optional Insurance) The Mountaineer Flexible Benefits program allows tax-free deductions for dental, vision, and disability insurance, as well as medical expenses not reimbursed…
Added 48 mins ago
Sr Manager BESS Engineering
Constellation Energy Generation, LLC.
Bow, NH
Provide overall management of engineering functional area of subject matter expertise to drive accountability, governance and oversight for the Constellation Power fleet. Manages the fleet…
Added 52 mins ago
G
Water/Wastewater Engineer
GPAC
Charlotte, NC
- $90,000 to $150,000 USD / year
Clear Growth Path: From Engineer → Project Manager → Technical Lead → Partner – we map it out with you.
Added 1 hour ago
Technical Program Manager III, AI Product Growth, Google Ads
Google
Mountain View, CA
…everyone, whether down the street or across the globe. As a Technical Program Manager at Google, you’ll use your technical expertise to lead complex, multi-disciplinary projects from start…
Added 1 hour ago
Technical Program Manager, Neutral Atoms, Quantum AI
Google
Boulder, CO
As a Technical Program Manager for the Quantum AI team, you usher complex, multi-disciplinary quantum computing projects through the entire project lifecycle using your engineering…
Added 1 hour ago
EG
Business Systems Analyst (BSA)
Eliassen Group
Cheyenne, WY
- $70 to $80 USD / hour
…communications, and organizational execution. This is not a traditional technical BSA or Project Manager role. The ideal candidate operates as a strategic generalist, helping create…
Added 1 hour ago
M
Principal Product Manager
Microsoft
WA · CA · Redmond, WA · Mountain View, CA · Redmond · Mountain View
- $142,800 to $304,200 USD / year
Working at the intersection of large language models, distributed systems, and reliability engineering, you will operate in a fast-paced, highly technical, and highly ambiguous environment…

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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