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Assistant Construction Manager - Global Facilities (Kansas City, MO)
Burns & McDonnell
Kansas City, MO
Description The Assistant Construction Manager plays a crucial role in the success of our Engineer Procure Construct (EPC) projects. This position is an opportunity to develop into a future…
Added 1 min ago
Assistant Construction Manager - Water (Kansas City, MO)
Burns & McDonnell
Kansas City, MO
…Project Manager, Project Manager, Site Manager, and/or the Engineer Procure Construct (EPC) Project Manager or Program Manager with day to day management of project safety, quality,…
Added 1 min ago
Construction Coordinator - (St. Louis)
Burns & McDonnell
Saint Louis, MO
The Construction Coordinator will assist with the administration of project safety, quality, schedule, cost control, contracts, subcontractors, suppliers, procurement, proposals, estimates,…
Added 3 mins ago
Senior Systems Health & Integrated Diagnostics Engineer
The Boeing Company
Berkeley, MO
Boeing Defense, Space & Security (BDS) is seeking a Senior Systems Health & Integrated Diagnostics Engineer (Level 5) to join the Reliability, Maintainability & System Health team in…
Added 3 mins ago
Senior Supplier Quality Engineer
MED Medtronic Inc
Mounds View, MN · Memphis, TN · North Haven, CT
Define component qualification strategies, including Production Part Approval Process (PPAP) requirements, qualification plans, control plans, and release readiness.
Added 3 mins ago
Principal Supplier Quality Engineer
MED Medtronic Inc
Mounds View, MN
The Principal Supplier Quality Engineer will lead quality activities for supplier transfers, providing Quality Assurance Engineering expertise across design transfer, manufacturing…
Added 4 mins ago
Project Manager - EPC Transmission & Distribution
Burns & McDonnell
Kansas City, MO
…management of project safety, engineering, quality, schedule, cost control, contracts, subcontractors, suppliers, proposals, estimates, documentation turnover, client relations, field…
Added 4 mins ago
Building Operations & Controls Engineer 3
Pacific Northwest National Laboratory
Jefferson City, MO
The Buildings Systems Group is seeking a Building Operations and Controls Engineer to join our team of building controls experts working to improve energy and water efficiency and…
Added 4 mins ago
Building Operations & Controls Engineer 2
Pacific Northwest National Laboratory
Jefferson City, MO
The Buildings Systems Group is seeking a Building Operations and Controls Engineer to join our team of building controls experts working to improve energy and water efficiency and…
Added 4 mins ago
Pipeline Client Service Manager/Project Manager
Kennedy/Jenks Consulting
Virginia Beach, VA
…contract negotiation, budget and schedule management, quality control, and risk…
Added 4 mins ago
Pipeline Client Service Manager/Project Manager
Kennedy/Jenks Consulting
Richmond, VA
…contract negotiation, budget and schedule management, quality control, and risk…
Added 4 mins ago
National Water Treatment Technical Expert
Kennedy/Jenks Consulting
Sacramento, CA
Guide development and provide quality control review of process flow diagrams, process design criteria, and process and instrumentation diagrams.
Added 4 mins ago
National Water Treatment Technical Expert
Kennedy/Jenks Consulting
San Diego, CA
Guide development and provide quality control review of process flow diagrams, process design criteria, and process and instrumentation diagrams.
Added 4 mins ago
National Water Treatment Technical Expert
Kennedy/Jenks Consulting
Pasadena, CA
Guide development and provide quality control review of process flow diagrams, process design criteria, and process and instrumentation diagrams.
Added 4 mins ago
National Water Treatment Technical Expert
Kennedy/Jenks Consulting
Portland, OR
Guide development and provide quality control review of process flow diagrams, process design criteria, and process and instrumentation diagrams.
Added 4 mins ago
Automation and AI Enablement Engineer
FiberFirst
Southlake, TX
…measured fact rather than an impression. The role suits an engineer with sound judgment about when to automate, when to apply a model, and when to leave a working system…
Added 4 mins ago
National Water Treatment Technical Expert
Kennedy/Jenks Consulting
Federal Way, WA
Guide development and provide quality control review of process flow diagrams, process design criteria, and process and instrumentation diagrams.
Added 5 mins ago
National Water Treatment Technical Expert
Kennedy/Jenks Consulting
Denver, CO
Guide development and provide quality control review of process flow diagrams, process design criteria, and process and instrumentation diagrams.
Added 4 mins ago
Commercial Security Systems Application Engineer/Strategic Accounts
Johnson Controls Inc.
United States
As an Application Engineer, you will work as part of a collaborative engineering team supporting one or more Strategic Accounts. In this role, you will be responsible for developing…
Added 5 mins ago
National Water Treatment Technical Expert
Kennedy/Jenks Consulting
Virginia Beach, VA
Guide development and provide quality control review of process flow diagrams, process design criteria, and process and instrumentation diagrams.
Added 5 mins ago
National Water Treatment Technical Expert
Kennedy/Jenks Consulting
Tampa, FL
Guide development and provide quality control review of process flow diagrams, process design criteria, and process and instrumentation diagrams.
Added 5 mins ago
National Water Treatment Technical Expert
Kennedy/Jenks Consulting
Fort Worth, TX
Guide development and provide quality control review of process flow diagrams, process design criteria, and process and instrumentation diagrams.
Added 5 mins ago
KC
Associate Engineer - Instrumentation & Controls
Kennedy/Jenks Consulting
Federal Way, WA
- $117,000 to $160,000 USD / year
Kennedy Jenks is seeking an Instrumentation and Controls Engineer to join our growing team in Federal Way, Washington. We are looking for a motivated professional with 5-8 years of…
Added 5 mins ago
KC
Associate Engineer - Instrumentation & Controls
Kennedy/Jenks Consulting
Portland, OR
- $107,000 to $147,000 USD / year
Kennedy Jenks is seeking an Instrumentation and Controls Engineer to join our growing team in Portland, Oregon. We are looking for a motivated professional with 5-8 years of experience in…
Added 5 mins ago
Senior Construction Manager (Water/Wastewater)
Kennedy/Jenks Consulting
Seattle, WA
…Contractor prepared construction schedules, and documentation control performed by the field…

Oracle

Principal Technical Curriculum Developer - 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, safet...

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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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