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Project Manager - Financial Monitoring
Houston-Galveston Area Council
Houston, TX
- $76,530 to $116,571 USD / year
The Project Manager oversees financial monitoring activities for the Gulf Coast Workforce Board’s program and contracted operations. The Agency contracts out more than $500 million in…
Added 1 min ago
Program Implementation Manager - Construction
Burns & McDonnell
Kansas City, MO
The Program Implementation Manager will support utility, industrial, and infrastructure owners in strengthening their organizational and process readiness for capital program success.…
Added 2 mins ago
Construction Quality Manager - Electrical & Instrumentation
Burns & McDonnell
Kansas City, MO
The Construction Quality Manager - Electrical & Instrumentation (E&I) is responsible for providing leadership, direction, and oversight of the electrical and instrumentation aspects of the…
Added 3 mins ago
Financial Controller-Manufacturing
Masters Transportation
Kansas City, MO
…opportunity for someone who can strengthen the financial processes, controls, cost accounting, and operational insights needed to support a growing bus manufacturing…
Added 3 mins ago
Procurement Agent – Millennium Space Systems
Millennium Space Systems
El Segundo, CA
…partners including Manufacturing, Supplier Quality, Engineering, Program Controls, Program Management, Shipping/Receiving/Inventory, Finance, Accounts Payable, and other supply chain areas…
Added 3 mins ago
IT SOX Specialist
The Boeing Company
Plano, TX · Chicago, IL · Kent, WA · Hazelwood, MO
Produce and deliver detailed operational reporting and dashboards for the IT SOX Senior Manager, FCG, Corporate Audit, and executive stakeholders; maintain program-level metrics and status.
Added 3 mins ago
DevOps Developer (Associate)
The Boeing Company
Seal Beach, CA
Automate, develop, monitor, improve, and troubleshoot across development, tooling, testing, integration, deployment, configuration processes, and security controls
Added 3 mins ago
MGR-ADMIN/CONTROLLER
Packaging Corporation of America
Gladstone, VA
…technology needs of the mill. The Administration and Controller Manager is involved in developing short and long-term plans and forecasts based on business goals; providing financial and…
Added 3 mins ago
Maintenance Supervisor
Packaging Corporation of America
Salt Lake City, UT
Salary Range $96,000 - $120,000 depending on technical certifications, Maintenance Manager Experience and Box Plant Maintenance Experience.
Added 3 mins ago
Maintenance Supervisor
Packaging Corporation of America
Salt Lake City, UT
Salary Range $96,000 - $120,000 depending on technical certifications, Maintenance Manager Experience and Box Plant Maintenance Experience.
Added 3 mins ago
SUPVR-MAINTENANCE
Packaging Corporation of America
Massillon, OH
Salary Range is dependent upon technical certifications, Maintenance Manager Experience and Box Plant Maintenance Experience.
Added 4 mins ago
Cyber Oracle Cloud Security - Consultant / Security Engineer II
Deloitte
Kansas City, MO
…environments. You will work with clients to assess risks, design controls, and implement security solutions that strengthen business processes and cloud…
Added 4 mins ago
Cyber - SAP Security and GRC Access & Process Control Consultant / Security Engineer II
Deloitte
Kansas City, MO
…access governance capabilities that help clients strengthen controls, manage risk, and support secure…
Added 4 mins ago
Cyber - SAP Security and GRC Access & Process Control Consultant / Security Engineer II
Deloitte
Saint Louis, MO
…access governance capabilities that help clients strengthen controls, manage risk, and support secure…
Added 5 mins ago
Cyber Oracle Cloud Security - Manager / Engineering Manager II
Deloitte
Kansas City, MO
…opportunities for growth and new responsibilities? As an Engineering Manager II in Deloitte's Cyber practice, you will help clients strengthen Oracle Cloud ERP, HCM, and SCM security by…
Added 5 mins ago
Cloud Security Manager - Azure Infrastructure & AI
Deloitte
Kansas City, MO
As a Cloud Security Manager on the Cloud Cyber Risk team, you will be responsible for:
Added 5 mins ago
GL
Associate Director, Commercial Quality Operations
Galderma Laboratories, LP
United States
- $156,000 to $187,200 USD / year
Establish release procedures, controls, and performance metrics.
Added 5 mins ago
Manager, Sales Force Effectiveness
Galderma Laboratories, LP
United States
The Manager, Sales Force Effectiveness (SFE) will help strengthen commercial performance by translating business strategy into effective field execution. Reporting to the Director of Sales…
Added 5 mins ago
Manager, Sales Force Effectiveness
Galderma Laboratories, LP
United States
The Manager, Sales Force Effectiveness (SFE) will help strengthen commercial performance by translating business strategy into effective field execution. Reporting to the Director of Sales…
Added 5 mins ago
Cloud Security Senior Consultant - M365
Deloitte
Kansas City, MO
…technologies include MFA, Conditional Access, Purview Compliance Manager, M365 Defender, Defender for O365, Defender for Cloud Apps (MDCA), Purview Information Protection (MPIP), Purview…
Added 5 mins ago
Chef Manager - Kirksville, MO
Compass Group, North America
Kirksville, MO
This is a _Great Opportunity_ to join a great company. We are seeking a growth minded Chef Manager for our growing business. In this role you will be responsible for the success of both the…
Added 5 mins ago
Project Controls Manager - Power/Oil, Gas & Chemical (Kansas City, MO)
Burns & McDonnell
Kansas City, MO
The Project Controls Manager is responsible for leadership, direction, management and performance of a project controls department. The Project Controls Manager is to assure that the…
Added 6 mins ago
EU
Employee Engagement Business Development Manager
Experis USA
Redmond, WA
- $49 to $52 USD / hour
Our client, is seeking a Business Development Manager to join their team. As a Business Development Manager, you will bridge business analytics, project management, and internal…
Added 6 mins ago
EU
Business Operations Manager
Experis USA
Redmond, WA
- $49 to $53 USD / hour
Our client is seeking a Business Operations Manager to join their team. As a Business Finance Manager, you will be part of the Commercial Strategy organization, supporting business…
Added 6 mins ago
Cloud Onboarding Manager 2
Experis USA
Redmond, WA
Our client, a high-growth, AI-powered global sales organization is seeking a Cloud Onboarding Manager 2 to join their team. As a Cloud Onboarding Manager 2, you will be part of the Copilot…

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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