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Added 24 mins ago
IS
Sr. Engineer
INSPYR Solutions
Fort Worth, TX
- $50 USD / hour
Support automation of activities such as user story creation, backlog management, and administrative workflows.
Added 30 mins ago
EG
Cloud Engineer
Eliassen Group
Juneau, AK
- $70 to $88 USD / hour
Our client seeks a senior Cloud Engineer to own and stabilize a legacy GCP and Azure footprint while assisting with conversions and decommissioning. The role will support automation efforts…
Added 30 mins ago
EG
Databricks Data Engineer
Eliassen Group
Juneau, AK
- $150,000 to $154,000 USD / year
Our client seeks a Databricks Data Engineer to design, build, and maintain scalable, reliable, and secure data pipelines, infrastructure, and systems that support consulting services and…
Added 40 mins ago
BH
Substation Engineer I, II, Senior, Lead or Principal
Black Hills Energy
Pueblo, CO
- $31,533 USD / year
…Under direct supervision, provide entry-level engineering and support to Black Hills Energy's electric utilities in substation design and electrical equipment upgrades.* Anticipate…
Added 40 mins ago
BH
Substation Engineer Senior, Lead or Principal ($10,000 sign-on bonus!)
Black Hills Energy
Golden, CO
- $31,533 USD / year
…Under direct supervision, provide entry-level engineering and support to Black Hills Energy's electric utilities in substation design and electrical equipment upgrades.* Anticipate…
Added 40 mins ago
JL
Property Condition Assessor
Jones Lang LaSalle
Denver, CO
- $55,000 to $80,000 USD / year
Support business development by presenting services to clients and contributing to revenue growth; some overnight travel required.
Added 40 mins ago
BH
Substation Engineer Senior, Lead or Principal ($10,000 sign-on bonus!)
Black Hills Energy
Golden, CO
- $31,533 USD / year
…Under direct supervision, provide entry-level engineering and support to Black Hills Energy's electric utilities in substation design and electrical equipment upgrades.* Anticipate…
Added 40 mins ago
BH
Substation Engineer I, II, Senior, Lead or Principal
Black Hills Energy
Pueblo, CO
- $31,533 USD / year
…Under direct supervision, provide entry-level engineering and support to Black Hills Energy's electric utilities in substation design and electrical equipment upgrades.* Anticipate…
Added 47 mins ago
Safety Engineer
Amentum
Houston, TX
Our long term client relationship with NASA has lead to a need for an early-career Safety and Environmental Health Engineer to support the Amentum JETS II Contract offsite and on-site…
Added 47 mins ago
Safety Engineer
Amentum
Houston, TX
Our long term client relationship with NASA has lead to a need for an early-career Safety and Environmental Health Engineer to support the Amentum JETS II Contract offsite and on-site…
Added 47 mins ago
Sr Ground Sys Engineer I, Mech 5672562003 Stennis
Rocket Lab USA
Stennis Space Center, MS
Added 47 mins ago
Sr. Project Engineer-R0007990
CF Industries Holdings, Inc.
Yazoo City, MS
Added 47 mins ago
Quality Engineer I 207462
Baxter Healthcare Corporation
Cleveland, MS
…than just a job-you will find purpose and pride. As a Quality Engineer I at Baxter Healthcare Corporation, you will have a meaningful role in ensuring the quality and reliability of our…
Added 47 mins ago
Product Engineer Senior / 10860 / Grenada
Modine Grenada LLC
Grenada, MS
Added 47 mins ago
Strategic Segment Proposal Engineer
ABB Inc
Southaven, MS
Added 47 mins ago
Traveling Senior Commissioning Manager - MSG - Dat
Turner Construction
Jackson, MS
…compliant project. Implement policies and procedures necessary to support project schedule, contractual obligations, and deliver fully compliant project. Coordinate with project site…
Added 48 mins ago
Mgr, Customer Service Support
Entergy
Jackson, MS
…customer service system data integrity, and for professional support of peers in customer service systems and…
Added 48 mins ago
EG
Databricks Data Engineer
Eliassen Group
Jackson, MS
- $150,000 to $154,000 USD / year
Our client seeks a Databricks Data Engineer to design, build, and maintain scalable, reliable, and secure data pipelines, infrastructure, and systems that support consulting services and…
Added 48 mins ago
EG
Cloud Engineer
Eliassen Group
Jackson, MS
- $70 to $88 USD / hour
Our client seeks a senior Cloud Engineer to own and stabilize a legacy GCP and Azure footprint while assisting with conversions and decommissioning. The role will support automation efforts…
Added 50 mins ago
Tier 3 Technical Support Engineer
CaseWorthy, LLC
Remote, United States
The Tier 3 Technical Support Engineer is the last line of technical defense before an issue reaches Engineering. You own the hardest customer problems: the ones Tier 1 and Tier 2 could not…
Added 54 mins ago
RE
Network Administrator I
Rochester Electronics, LLC
Newburyport, MA
- $63,000 to $85,680 USD / year
Assist and support the Network Engineer with projects, upgrades, maintenance, and troubleshooting.
Added 55 mins ago
EG
Cloud Engineer
Eliassen Group
Charleston, WV
- $70 to $88 USD / hour
Our client seeks a senior Cloud Engineer to own and stabilize a legacy GCP and Azure footprint while assisting with conversions and decommissioning. The role will support automation efforts…
Added 55 mins ago
EG
Databricks Data Engineer
Eliassen Group
Charleston, WV
- $150,000 to $154,000 USD / year
Our client seeks a Databricks Data Engineer to design, build, and maintain scalable, reliable, and secure data pipelines, infrastructure, and systems that support consulting services and…
Added 1 hour ago
EG
Cloud Engineer
Eliassen Group
Lincoln, NE
- $70 to $88 USD / hour
Our client seeks a senior Cloud Engineer to own and stabilize a legacy GCP and Azure footprint while assisting with conversions and decommissioning. The role will support automation efforts…
Added 1 hour ago
EG
Databricks Data Engineer
Eliassen Group
Lincoln, NE
- $150,000 to $154,000 USD / year
Our client seeks a Databricks Data Engineer to design, build, and maintain scalable, reliable, and secure data pipelines, infrastructure, and systems that support consulting services and…

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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