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887082 - GOVERNMENT ANALYST II
MyFlorida
TALLAHASSEE, FL
This is a professional position that reports to the Contracts & Grants Manager-SES . The incumbent serves as a team member and special projects coordinator between the Division of Workforce…
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Cyber Security Manager - Diego Garcia
Amentum
Tallahassee, FL
The FRCS Cybersecurity Manager will install, configure, calibrate, operate, and maintain hardware and software of IT, and OT of FRCS. The FRCS Cybersecurity Manager will employ user access…
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Integrated Product Team Lead
L3Harris
Orlando, FL
…technical progress, risk, and schedule while ensuring product quality. This position is primarily responsible for ensuring their product meets the system’s requirements and coordinates any…
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EG
Business Systems Analyst (BSA)
Eliassen Group
Tallahassee, FL
- $70 to $80 USD / hour
Our client is seeking a highly proactive and versatile Business Systems Analyst (BSA) to support senior leadership and cross-functional teams with strategic planning, portfolio operations,…
Added 3 mins ago
S
Associate Specialist, Corporate Communications
SHRM
Alexandria, VA
- $65,000 to $75,000 USD / year
Reporting to the Manager, CEO Communications, the Associate Specialist works collaboratively with internal stakeholders to support communications projects, employee engagement activities,…
Added 5 mins ago
Systems Engineering Section Manager 2
Northrop Grumman
Iuka, MS · Iuka
Northrop Grumman Aerospace Systems has an opening for a System Engineering Section Manager on the STRIKE program to join our team of qualified individuals. This position will be located in…
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Manager Supply Chain Programs 2
Northrop Grumman
Palmdale, CA · Palmdale
Northrop Grumman Aeronautics Systems has an opening for a Manager Supply Chain Programs 2 to join our team of qualified and diverse individuals within our Global Supply Chain organization.…
Added 16 mins ago
Quality Control Manager | Federal Construction
GPAC
Norfolk, VA
A nationally recognized general contractor is seeking an experienced Quality Control Manager to lead quality assurance and compliance on high-profile federal construction projects. With a…
Added 16 mins ago
Quality Control Manager | Federal Construction
GPAC
Jacksonville, NC
A nationally recognized general contractor is seeking an experienced Quality Control Manager to lead quality assurance and compliance on high-profile federal construction projects. With a…
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Quality Control Manager | Federal Construction
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Colorado Springs, CO
A nationally recognized general contractor is seeking an experienced Quality Control Manager to lead quality assurance and compliance on high-profile federal construction projects. With a…
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Quality Control Manager | Federal Construction
GPAC
Panama City, FL
A nationally recognized general contractor is seeking an experienced Quality Control Manager to lead quality assurance and compliance on high-profile federal construction projects. With a…
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Quality Control Manager | Federal Construction
GPAC
Omaha, NE
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Quality Control Manager | Federal Construction
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Rapid City, SD
A nationally recognized general contractor is seeking an experienced Quality Control Manager to lead quality assurance and compliance on high-profile federal construction projects. With a…
Added 20 mins ago
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Child Welfare Continuous Quality Improvement Expert
JBS International
North Bethesda, MD · San Mateo, CA · CA · DC · MD · VA
- $80,000 to $108,500 USD / year
Distills complex information into key ideas and concepts and makes information easily accessible to child welfare professionals for the purpose of program improvement and systems change
Added 27 mins ago
Resident Care Manager - RN
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Wilsonville, OR
As a Resident Care Manager (RCM) your experienced nursing skills will be utilized as you conduct and coordinate the development and completion of the resident assessments (MDS) in…
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Resident Care Manager In-Training Program - RN
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Resident Care Manager (RCM) - RN
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Portland, OR
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Added 28 mins ago
Business Development Analyst Senior
Amerihealth Caritas
United States
…Caritas products. Under the direction of the Business Development Program Manager, the Senior Business Development Analyst supports business development initiatives through market and…
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Senior HVAC Project Manager
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Sacramento, CA
- $100,000 to $135,000 USD / year
We’re seeking a Senior HVAC Project Manager to lead complex mechanical projects from start to finish.
Added 34 mins ago
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Senior HVAC Project Manager
GPAC
San Francisco, CA
- $100,000 to $135,000 USD / year
We’re seeking a Senior HVAC Project Manager to lead complex mechanical projects from start to finish.
Added 34 mins ago
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Senior HVAC Project Manager
GPAC
San Diego, CA
- $100,000 to $135,000 USD / year
We’re seeking a Senior HVAC Project Manager to lead complex mechanical projects from start to finish.
Added 34 mins ago
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Senior HVAC Project Manager
GPAC
Los Angeles, CA
- $100,000 to $135,000 USD / year
We’re seeking a Senior HVAC Project Manager to lead complex mechanical projects from start to finish.
Added 34 mins ago
G
Senior HVAC Project Manager
GPAC
San Francisco, CA
- $100,000 to $135,000 USD / year
We’re seeking a Senior HVAC Project Manager to lead complex mechanical projects from start to finish.
Added 34 mins ago
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Senior HVAC Project Manager
GPAC
San Diego, CA
- $100,000 to $135,000 USD / year
We’re seeking a Senior HVAC Project Manager to lead complex mechanical projects from start to finish.

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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