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Added 4 mins ago
Production Team Lead
Illinois Tool Works Inc.
United States
…and daily production performance. The role works closely with Engineering, Manufacturing Engineering / Quality, Supply Chain, Logistics and Customer Experience to maintain material and…
Added 5 mins ago
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Maintenance Engineer
GPAC
Golden Valley, MN
- $34 to $41 USD / hour
…wants to expand beyond plant maintenance and gain exposure to process engineering, customer applications, and advanced food processing…
Added 5 mins ago
G
Maintenance Engineer
GPAC
Hopkins, MN
- $34 to $41 USD / hour
…wants to expand beyond plant maintenance and gain exposure to process engineering, customer applications, and advanced food processing…
Added 5 mins ago
G
Maintenance Engineer
GPAC
Maple Grove, MN
- $34 to $41 USD / hour
…wants to expand beyond plant maintenance and gain exposure to process engineering, customer applications, and advanced food processing…
Added 5 mins ago
G
Maintenance Engineer
GPAC
Long Lake, MN
- $34 to $41 USD / hour
…wants to expand beyond plant maintenance and gain exposure to process engineering, customer applications, and advanced food processing…
Added 5 mins ago
G
Maintenance Engineer
GPAC
Loretto, MN
- $34 to $41 USD / hour
…wants to expand beyond plant maintenance and gain exposure to process engineering, customer applications, and advanced food processing…
Added 5 mins ago
G
Maintenance Engineer
GPAC
Hamel, MN
- $34 to $41 USD / hour
…wants to expand beyond plant maintenance and gain exposure to process engineering, customer applications, and advanced food processing…
Added 5 mins ago
G
Maintenance Engineer
GPAC
Plymouth, MN
- $34 to $41 USD / hour
…wants to expand beyond plant maintenance and gain exposure to process engineering, customer applications, and advanced food processing…
Added 5 mins ago
G
Maintenance Engineer
GPAC
New Hope, MN
- $34 to $41 USD / hour
…wants to expand beyond plant maintenance and gain exposure to process engineering, customer applications, and advanced food processing…
Added 5 mins ago
G
Maintenance Engineer
GPAC
New Hope, MN
- $34 to $41 USD / hour
…wants to expand beyond plant maintenance and gain exposure to process engineering, customer applications, and advanced food processing…
Added 5 mins ago
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Maintenance Engineer
GPAC
Minnetonka, MN
- $34 to $41 USD / hour
…wants to expand beyond plant maintenance and gain exposure to process engineering, customer applications, and advanced food processing…
Added 7 mins ago
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Process Engineer
GPAC
Dayton, OH
- $90,000 USD / year
We are a Plastic Molding Manufacturer looking for a Process Engineer. We have been highly regarded for over 20 years and offer a wonderful stable working environment. If it's plastic we can…
Added 10 mins ago
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Tooling Engineer
GPAC
Canton, OH
- $80,000 to $105,000 USD / year
…aerospace industries. We are looking for an experienced Tooling Engineer to drive tooling design, process improvement, and manufacturing excellence across our…
Added 13 mins ago
Civil Structural Engineer
GPAC
Chicago, IL
We are seeking a Structural Design Engineer to join our growing team. This role offers the opportunity to participate in every phase of structural engineering projects, from preliminary…
Added 14 mins ago
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Sales Engineer
GPAC
Elyria, OH
- $70,000 to $110,000 USD / year
Position Summary: The Sales Engineer will support the company’s strategic growth by identifying and developing new opportunities in both existing and potential markets. This role requires a…
Added 14 mins ago
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Tooling Engineer
GPAC
Columbus, OH
- $80,000 to $105,000 USD / year
We are looking for an experienced Tooling Engineer to drive tooling design, process improvement, and manufacturing excellence across our operations.
Added 14 mins ago
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Sr. Electrical Engineer/Project Manager
GPAC
Columbus, OH
- $95,000 to $155,000 USD / year
A reputable and established multi-disciplinary Engineering firm is looking for a Senior Electrical Engineer/Project Manager, with a passion to deliver excellence! This firm works hard to…
Added 14 mins ago
G
Tooling Engineer
GPAC
Bay Village, OH
- $80,000 to $105,000 USD / year
…aerospace industries. We are looking for an experienced Tooling Engineer to drive tooling design, process improvement, and manufacturing excellence across our…
Added 15 mins ago
Civil Structural Engineer
GPAC
Dallas, TX
We are seeking a Structural Design Engineer to join our growing team. This role offers the opportunity to participate in every phase of structural engineering projects, from preliminary…
Added 15 mins ago
G
Sr. Electrical Engineer/Project Manager
GPAC
Dallas, TX
- $95,000 to $155,000 USD / year
A reputable and established multi-disciplinary Engineering firm is looking for a Senior Electrical Engineer/Project Manager, with a passion to deliver excellence! This firm works hard to…
Added 15 mins ago
Civil Engineer - Land Development
GPAC
Nashville, TN
We are seeking a Civil Design Engineer with experience in land development to support a variety of residential, commercial, and mixed-use projects. In this role, you'll contribute to…
Added 15 mins ago
Civil Engineer - Land Development
GPAC
Camp Hill, PA
We are seeking a Civil Design Engineer with experience in land development to support a variety of residential, commercial, and mixed-use projects. In this role, you'll contribute to…
Added 16 mins ago
Civil Engineer - Land Development
GPAC
York, PA
We are seeking a Civil Design Engineer with experience in land development to support a variety of residential, commercial, and mixed-use projects. In this role, you'll contribute to…
Added 16 mins ago
Civil Engineer - Land Development
GPAC
Savannah, GA
We are seeking a Civil Design Engineer with experience in land development to support a variety of residential, commercial, and mixed-use projects. In this role, you'll contribute to…
Added 18 mins ago
CO
Development Project Manager II
City of San Diego
San Diego, CA
- $55.75 to $67.32 USD / hour
…aspects; resolve all outstanding and/or conflicting project or process issues; identify all stakeholder needs and ensure customer service standards are achieved and/or exceeded; and perform…

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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