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Reliability Engineer
Louisville, CO · Salt Lake City, UT · Houston, TX
A day in the life of an AES Clean Energy Reliability Engineer will include, but is not limited to:
Added 4 mins ago
Senior Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Redmond, WA
· Develop embedded software for Customer Terminal devices within the Project Leo system.
Added 4 mins ago
Software Development Manager
Amazon Kuiper Manufacturing Enterprises LLC
Redmond, WA
…customers and communities around the world, and we’ve designed the system with the capacity, flexibility, and performance to serve a wide range of customers, from individual households to…
Added 4 mins ago
Sr. Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX · Redmond, WA
· Develop embedded software for Customer Terminal devices within the Project Leo system.
Added 4 mins ago
Sr. Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX · Redmond, WA
· Develop embedded software for Customer Terminal devices within the Project Leo system.
Added 4 mins ago
Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX
· Develop embedded software for Customer Terminal devices within the Project Leo system.
Added 4 mins ago
Sr. Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX · Redmond, WA
· Develop embedded software for Customer Terminal devices within the Project Leo system.
Added 4 mins ago
Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX · Redmond, WA
· Develop embedded software for Customer Terminal devices within the Project Leo system.
Added 4 mins ago
Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX · Redmond, WA
· Develop embedded software for Customer Terminal devices within the Project Leo system.
Added 4 mins ago
Sr. Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX · Redmond, WA
· Develop embedded software for Customer Terminal devices within the Project Leo system.
Added 4 mins ago
Sr. Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX · Redmond, WA
· Develop embedded software for Customer Terminal devices within the Project Leo system.
Added 4 mins ago
Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX · Redmond, WA
· Develop embedded software for Customer Terminal devices within the Project Leo system.
Added 4 mins ago
Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX · Redmond, WA
· Develop embedded software for Customer Terminal devices within the Project Leo system.
Added 5 mins ago
Application Engineer
PulseForge, Inc.
Austin, TX
Job Description – Application Development Engineer
Added 6 mins ago
Senior Quality Engineer
MinebeaMitsumi Companies
Chatsworth, CA
The Senior Quality Assurance Engineer will be responsible for compliance to AS9100, quality requirements of NHBB’s customers and driving projects for reduction of scrap and rework processes
Added 7 mins ago
Specialist, Software Engineering 1 1
L3Harris Technologies
Carlsbad, CA · Salt Lake City, UT
L3Harris seeks skilled Software Engineer to join our System Software group, where you will architect next-generation, mission-critical solutions. Our team is responsible for developing the…
Added 8 mins ago
IG
Fire Control Systems Engineer (TSSCI)
Insight Global
Dahlgren, VA
- From $71 USD / hour
Insight Global is seeking a Fire Control Systems Engineer to support a dynamic systems engineering team at Naval Surface Warfare Center Dahlgren Division.
Added 8 mins ago
IG
Mission Planning Systems Engineer (TSSCI)
Insight Global
Dahlgren, VA
- From $71 USD / hour
Insight Global is seeking a Mission Planning Systems Engineer to support a dynamic systems engineering team at Naval Surface Warfare Center Dahlgren Division.
Added 11 mins ago
Staff Machine Learning Engineer
ServiceNow
Santa Clara, CA
It all started when engineer Fred Luddy wrote code that automated a tedious task for his coworker, Phyllis. She cried tears of joy. That moment inspired Fred to build a company that could…
Added 11 mins ago
Distinguished Platform Engineer
ServiceNow
Santa Clara, CA
It all started when engineer Fred Luddy wrote code that automated a tedious task for his coworker, Phyllis. She cried tears of joy. That moment inspired Fred to build a company that could…
Added 11 mins ago
Quality Engineer
Hennig
United States
The Quality Engineer will be responsible for the continuous improvement of Hennig Incorporated's Quality Management System. This includes developing, implementing, and maintaining strategic…
Added 11 mins ago
CO
Core Research Software Engineer I - Integrated Genomics Core
Career Opportunities
La Jolla, CA
- $33 to $38 USD / hour
The Salk Institute Core Facilities are looking for a Research Software Engineer to assist in daily systems administration and operational support for the technology infrastructure that…
Added 12 mins ago
Systems Engineering and Integration Support - Weapons System Modernization
BAE Systems
Rockville, MD
Job Description Are you willing to learn and collaborate with an expansive team of talented system and software engineers on the modernization of hardware and migration of software on…
Added 13 mins ago
C
Principal Robotic Controls Engineer
Clera
San Francisco, CA
- $250,000 to $315,000 USD / year
- Design control architecture for coarse gimbals and fine steering mirrors, including bandwidth allocation, multi-rate operation, and stage handoffs.
Added 14 mins ago
Sr. Manufacturing Engineer / Quality Engineer
Hydraulic Technologies USA, LLC
Rockford, IL
We are seeking an experienced, hands‑on Manufacturing/Quality Engineer to support daily production, improve processes, and ensure product quality in a machining and assembly 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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