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Added 33 mins ago
F-15 Mission Systems Software Engineer (Associate, Experienced, & Senior)
The Boeing Company
Berkeley, MO
The Boeing Company is looking for a Software Engineer (Associate, Experienced, & Senior) to join the F-15 Mission System Software Development Team located in Berkeley, MO. This position…
Added 1 hour ago
Test Systems Development Engineer I
Abbott
Burlington, MA
The Test Systems Development Engineer I develops automated test systems, fixtures, equipment, and methodologies to support the research, development, characterization, and verification of…
Added 1 hour ago
Software Development Engineer, OneMHS
Amazon
Boston, MA
We are seeking an exceptional Software Development Engineer to build and scale edge machine learning compute, equipment monitoring, and computer vision capabilities across our global…
Added 1 hour ago
Staff Software Engineer - Virtualization
General Motors
Jefferson City, MO
General Motors is seeking a Staff Software Engineer to shape and scale the engineering platforms that build, test, integrate, validate, and deliver embedded software for software-defined…
Added 2 hours ago
O
Principal Application Software Engineer, Java & Cloud
Oracle
Jefferson City, MO
- $99,600 to $209,500 USD / year
Oracle Cloud Infrastructure (OCI) is looking for a Principal Application Software Engineer to help develop and evolve TDMS, a mission-critical software suite supporting manufacturing…
Added 2 hours ago
O
Advanced Services Engineer- Must Have Oracle Health Patient Accounting-Local to Cleveland, OH
Oracle
Cleveland, OH
- $25.87 to $63.65 USD / hour
Assist with configuration and updates: Perform routine application configuration, software updates, upgrades, and validation activities, seeking guidance when needed.
Added 3 hours ago
CI
Embedded Controls Verification Engineer
Cintal, Inc.
Chillicothe, IL
- $80,000 to $105,000 USD / year
Collaborate with embedded controls and software engineers to validate new features and debug issues.
Added 3 hours ago
Software Lead Engineer
GE Aerospace
Evendale, OH
The Software Lead Engineer is the technical lead for embedded engine control software. You'll own the design of highly complex modules, critical components, or a whole software product, and…
Added 3 hours ago
Engineer: Motor Control - experienced (Aerospace)
PARKER HANNIFIN CORPORATION
Elyria, OH
…requirements into robust, manufacturable electrical hardware and embedded-control solutions. Responsibilities include supporting power electronics and control-circuit design, embedded…
Added 3 hours ago
Principal Software Engineer
Riverside Research Institute
Dayton, OH
Software Engineer Location US-OH-Beavercreek ID 2026-4457 Category Software Development Position Type Full Time Salary Riverside Overview Riverside Research is an independent National…
Added 3 hours ago
Principal Software Engineer
Riverside Research Institute
Dayton, OH
Software Engineer Location US-OH-Beavercreek ID 2026-4460 Category Research & Development Position Type Full Time Salary Riverside Overview Riverside Research is an independent National…
Added 3 hours ago
Software Engineer 2 - Mobile Developer (iOS & Android)
U.S. Bank
Cincinnati, OH
Exhibits relentless focus on software reliability engineering standards embedded into development practices
Added 3 hours ago
T
Engineer Signal Image Processing 2
TEKsystems
Cincinnati, OH
- $40 to $50 USD / hour
We are seeking a highly skilled Sr. Principal Digital Signal Processing Engineer to develop advanced signal processing solutions supporting mission-critical applications. This role is ideal…
Added 3 hours ago
Experienced Application Software Engineer - Cincinnati, OH
ICIMS - Lutron Electronics Company, Inc
Cincinnati, OH
Lutron Electronics Company, Inc Experienced Application Software Engineer - Cincinnati, OH US-OH-Cincinnati Job ID: 2026-5067 # of Openings: 1 Category: Engineering Lutron - Cincinnati, OH…
Added 3 hours ago
Automation Developer Analyst
Altimetrik, Inc
Cincinnati, OH
…and manage Docusign components such as envelopes, templates, embedded signing and workflows. Collaborate with cross-functional teams to gather and analyze complex business requirements and…
Added 4 hours ago
Staff Embedded Software Engineer – AUTOSAR, Platform Software
Lucid Motors
Newark, CA
Proven track record in developing and delivering AUTOSAR-compliant software for embedded systems
Added 4 hours ago
Senior Principal Engineer- Autonomous Driving (ADAS) Data Loop & Flywheel
Bosch Group
Sunnyvale, CA
You will serve as the chief technical authority driving the software, data loop, and MLOps machinery that automatically ingests raw fleet logs, curates high-value edge cases, auto-labels…
Added 5 hours ago
O
Lead Principal Platform Software Engineer
Oracle
Nashville, TN
- $113,600 to $306,400 USD / year
We are seeking a Lead Principal Software Engineer to set long-term technical direction for the Robotics Automation Platform. You will lead architecture and technical delivery across…
Added 5 hours ago
O
Senior Platform Software Engineer
Oracle
Nashville, TN
- $87,800 to $209,500 USD / year
Software Engineer - OCI User Experience Engineering Platform
Added 5 hours ago
O
Manager, Application Software Engineering
Oracle
Austin, TX
- $114,600 to $234,600 USD / year
You will combine people leadership, engineering execution, and technical transformation to improve delivery, strengthen software quality, and build the team’s capabilities in AI-assisted…
Added 6 hours ago
Embedded Software Engineer II
Wabtec Corporation
Germantown, MD
…Systems, and Train Control Equipment. In this role, the Senior Embedded Software Engineer will work with a cross-functional Engineering team to design and develop new functionalities, as…
Added 6 hours ago
Avionics Test Engineer I- Onsite
RTX Corporation
annapolis, MD
We are seeking a highly motivated Avionics Test Engineer to join our Systems Engineering team. In this role, you will support the testing and verification of avionics hardware using…
Added 6 hours ago
Mechatronics Controls Engineer
Apple
Sunnyvale, CA
…future. One of Apple’s R&D groups is seeking a Robotics Controls Engineer to develop, prototype, and validate complex, next-generation systems. In this role, you will build capabilities to…
Added 6 hours ago
Senior Firmware Engineer
NVIDIA USA
CA
NVIDIA seeks a resourceful, highly motivated engineer experienced in microcontroller system software to become part of the Tegra System Software group. Our team pushes technology beyond…
Added 6 hours ago
Hardware Validation Engineer
NVIDIA USA
OR
We seek a HW Validation Engineer to join our System Products Team. This role offers you the ability to assist in building NVIDIA’s next generation of high-performance computing products.…

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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