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Added 1 min ago
Sous Chef (Japanese Cuisine), Operations
Gate Gourmet, Inc
Honolulu, HI
Candidate must be comfortable with all levels of employees and have the ability to drive positive program change.
Added 3 mins ago
Senior Quality Leader
Sylvamo
Eastover, SC
Coach and mentor quality technicians and provide technical guidance to operations and engineering teams.
Added 3 mins ago
Engineering Manager(Manufacturing)
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Represent Manufacturing Engineering in customer audits, technical reviews, and program meetings.
Added 4 mins ago
Engineering Services Project Manager (Onsite)
ORBIS Corporation
Remote, United States
Provides technical sales support to develop new opportunities for services and/or product revenue.
Added 5 mins ago
A
Scientist/Geoscientist
AECOM
Anchorage, AK
- $83,000 to $120,000 USD / year
This position will be on either a project management or technical support track. Qualified candidates (or candidates with the desire to take on these roles) would work closely with…
Added 5 mins ago
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Senior NEPA Compliance Project Manager
AECOM
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- $120,000 to $160,000 USD / year
…planners, designers, engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a positive and tangible impact…
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Manager / Senior Manager, Data Products & Programs
Simon & Schuster
New York, NY
…everyday work and enable faster, better-informed decisions. The Manager or Senior Manager, Data Products & Programs will lead a portfolio of data- and AI-enabled software initiatives from…
Added 7 mins ago
Technical Project Manager
Autoscience
Menlo Park, CA
- Experience as a Project Manager, Program Manager, or Technical Program Manager at a fast moving software or AI company
Added 13 mins ago
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Program Business Manager - Secret
Insight Global
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- $150,000 USD / year
Experience working in a SAP (Special Access Program) environment
Added 15 mins ago
Project Manager (Remote)
HOME DEPOT MANAGEMENT COMPANY, LLC
Remote, United States
The Project Manager is responsible for a combination of planning and execution of activities related to delivery of projects and/or financial/budgeting activity for their teams. When…
Added 17 mins ago
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L&I DOSH Industrial Hygiene Compliance Investigator 1, 2, OR 3 Reg 1
State of Washington
Bellingham, WA · Mount Vernon, WA · Everett, WA
- $5,376 to $9,246 USD / month
…workplace environmental hazards? Do you want to apply your technical expertise in occupational exposure assessment to make Washington’s workplaces…
Added 17 mins ago
Portfolio Manager, Data & AI Governance, Enablement & Literacy
General Motors LLC
Remote, United States
Bachelor's degree in Computer Science, Engineering, Information Systems, Cybersecurity, or a related technical field.
Added 18 mins ago
Account Sales Executive (2026-047)
Circle Cardiovascular Imaging
Remote, United States
…rates than the hospital OPPS setting. The ASE must understand technical, professional, and global billing and how reimbursement shapes what a center can afford and where it makes…
Added 18 mins ago
Account Sales Executive (2026-047)
Circle Cardiovascular Imaging
Remote, United States
…rates than the hospital OPPS setting. The ASE must understand technical, professional, and global billing and how reimbursement shapes what a center can afford and where it makes…
Added 18 mins ago
Account Sales Executive (2026-047)
Circle Cardiovascular Imaging
Remote, United States
…rates than the hospital OPPS setting. The ASE must understand technical, professional, and global billing and how reimbursement shapes what a center can afford and where it makes…
Added 18 mins ago
Account Sales Executive (2026-047)
Circle Cardiovascular Imaging
Remote, United States
…rates than the hospital OPPS setting. The ASE must understand technical, professional, and global billing and how reimbursement shapes what a center can afford and where it makes…
Added 18 mins ago
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AI Product Manager
Globality, Inc.
Palo Alto, CA
- $150,000 to $250,000 USD / year
As an AI Product Manager, you will own the agent and AI layer of Glo, including the product decisions behind how it is designed and implemented, from agent architecture and orchestration to…
Added 19 mins ago
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Senior Product Manager, Community & Campaigns
CreatorIQ
Remote, United States
- $121,000 to $145,000 USD / year
We’re looking for a Senior Product Manager to own the part of CreatorIQ where the work actually happens. Community is the creator CRM: the roster, the relationships, the lifecycle, the…
Added 19 mins ago
Telecommunications Engineer 4 - Tysons, VA
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Tysons, VA
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Added 19 mins ago
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Project Administrator, Staff
M.C. Dean, Inc
Frederick, MD
- $26.77 to $30.11 USD / hour
Our people are passionate about engineering innovation that improves lives and drives impactful change. Guided by our core values - agility, expertise, and trust - we foster a collaborative…
Added 19 mins ago
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Tysons, VA
Our people are passionate about engineering innovation that improves lives and drives impactful change. Guided by our core values - agility, expertise, and trust - we foster a collaborative…
Added 19 mins ago
Telecommunications Specialist 4 (Technical Specialist 4) - Tysons, VA
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The specialist is the technical authority for inside plant (ISP) and outside plant (OSP) infrastructure on assigned task orders. This includes cabling, equipment, pathways, spaces, and…
Added 23 mins ago
Project Director Transportation
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Added 23 mins ago
Lead Program Manager
Arcadis
Chicago
Arcadis is seeking an experienced Lead Program Manager to join our Chicago team. This individual will lead the planning and delivery of complex capital programs for public- and…
Added 23 mins ago
Cost Manager / Quantity Surveyor - Data Center Construction
Turner & Townsend
Indianapolis, IN
Turner & Townsend are looking for a Cost Manager to join our team and support construction cost services on a large-scale data center program located in Jefferson, approximately 40 miles…

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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