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GA
Sr Manufacturing Engineer - Sourced Hardware
GE Aerospace
Baltimore, MD
- $116,000 to $155,000 USD / year
The Senior Manufacturing Engineer will manage and coordinate delivery projects within the Supplier Performance & Execution Sourcing Section. You will organize and coordinate…
Added just now
Advanced Lead Supplier Quality Engineer - Composites
GE Aerospace
Baltimore, MD
The Supplier Quality Engineer for Polymer Matrix Composites is an individual who can apply knowledge of RCCA and/or problem solving to lead supplier quality improvement of complex cross…
Added just now
Senior Design Manager (Data Center)
Jacobs
Baltimore, MD
Lead development of air-cooled, liquid-cooled, and hybrid cooling solutions, including direct-to-chip cooling, CDUs, rack manifolds, technology cooling water interfaces, leak detection, and…
Added just now
Senior Lead Engineer
PwC
Baltimore, MD
As a Senior Lead Engineer you will lead custom application development and testing efforts that help clients turn business needs into scalable software solutions across cloud-native and…
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Lead Engineer
PwC
Baltimore, MD
As a Lead Engineer you will guide the design, build, testing, and modernization of custom applications across cloud-native and on-premise environments, using modern engineering approaches,…
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Senior Engineer
PwC
Baltimore, MD
As a Senior Engineer you will help design, build, and test custom applications within our Advisory practice, bringing together software engineering, cloud-based solution delivery, and…
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Junior Developer
SkillStorm
Baltimore, MD
…first day, with a defined path from trainee to client-ready…
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Construction Engineer, Civil
Washington Metropolitan Area Transit Authority
Bowie, MD
This is a hybrid opportunity, with a flexible work schedule that is within the Joint Development Adjacent Construction Division (JDAC) with the Washington Metropolitan Area Transit…
Added just now
Electro-Optic Infrared Engineer
BOOZ, ALLEN & HAMILTON, INC.
Patuxent, MD
As an electrical engineer, you understand the workings behind complex systems. That knowledge is key when it comes to designing and integrating radar systems. We're looking for an…
Added 1 min ago
CO
Senior Civil Engineer - Public Works
City of Oxnard
Oxnard, CA
- $53.19 to $85.1 USD / hour
The City of Oxnard’s Public Works Department is seeking a Senior Civil Engineer to provide engineering leadership, oversee capital improvement projects, and support the delivery of the…
Added 2 mins ago
Vice President, Cloud Platform Engineer
SitusAMC
Santa Fe, NM
…Terraform, AWS Services, Docker, Kubernetes, and familiar with Git development. The Engineer is expected to provide strategy and implement enterprise-scale automation for scalability,…
Added 2 mins ago
Senior Telecom Engineer
Maximus
Santa Fe, NM
Maximus is seeking an experienced Senior Telecom Engineer to lead the design, implementation, and optimization of Genesys Cloud solutions. This role is responsible for executing large-scale…
Added 2 mins ago
Connectivity Engineer - Data Center Design, Engineering, & Construction
Meta
Los Lunas, NM
Meta is seeking a Connectivity Engineer to join the Edge & Network Services (ENS) team. Our data centers are the foundation upon which our services are delivered, and our rapidly scaling…
Added 2 mins ago
Network Engineer, Data Center Field Operations
Meta
Los Lunas, NM
Meta is looking for a Data Center Field Operations Network Engineer to support delivery of field services as part of our Edge and Network Services (ENS) team. The role requires subject…
Added 2 mins ago
Senior Design Manager (Data Center)
Jacobs
Clovis, NM
Lead development of air-cooled, liquid-cooled, and hybrid cooling solutions, including direct-to-chip cooling, CDUs, rack manifolds, technology cooling water interfaces, leak detection, and…
Added 2 mins ago
Lead Release Train Engineer
Humana
Santa Fe, NM
The Lead Release Train Engineer (RTE) serves as the servant leader, facilitator, and coach for a complex Agile Release Train (ART), supporting multiple Scrum teams in delivering business…
Added 2 mins ago
EG
QA Automation Engineer
Eliassen Group
Santa Fe, NM
- $75 to $82 USD / hour
Participate and contribute to requirements analysis, design, QA test plan development, defect review, QA results analysis, sprint review, and project planning sessions.
Added 2 mins ago
EG
Staff AI & Data Engineer – Databricks
Eliassen Group
Santa Fe, NM
- $80 to $90 USD / hour
Our client is seeking a highly experienced Staff AI & Data Engineer to design and build enterprise-grade data and AI solutions on Databricks. This hands-on role focuses on strengthening the…
Added 2 mins ago
Transportation Engineer
GPAC
Chicago, IL
Civil Roadway/Transportation Design Engineer with responsible for the planning, design, and development of transportation and roadway infrastructure projects from preliminary concepts…
Added 3 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 4 mins ago
Civil Engineer - Land Development
GPAC
York, PA
…experienced engineers and project managers to deliver innovative land development projects throughout the York area. This is an excellent opportunity for an engineer who enjoys…
Added 4 mins ago
Production Team Lead
Illinois Tool Works
Carol Stream, IL
Partner with the Manufacturing Engineer to improve assembly methods, layouts, standard work and production readiness for new or changed products; ensure agreed changes are implemented,…
Added 4 mins ago
Civil Engineer - Land Development
GPAC
Harrisburg, PA
…experienced engineers and project managers to deliver innovative land development projects throughout the Camp Hill area. This is an excellent opportunity for an engineer who enjoys…
Added 5 mins ago
Civil Engineer - Land Development
GPAC
Savannah, GA
…experienced engineers and project managers to deliver innovative land development projects throughout the Savannah area. This is an excellent opportunity for an engineer who enjoys…
Added 5 mins ago
Water/Wastewater Engineer
GPAC
Savannah, GA
We are actively seeking an initiative-taking Water/Wastewater Engineer your area that can be a role model, client-focused, impactful, and decisive. Work on rewarding projects within a…

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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