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Added 2 mins ago
Laboratory Technician
University of Pittsburgh
Pittsburgh, PA
…generation of scientists and public health professionals to lead in the effort to reduce the impact of infectious diseases…
Added 5 mins ago
J
SENIOR NETWORK SECURITY ENGINEER
Jobgether
Remote, United States
- $120,000 to $140,000 USD / year
The Senior Network Security Engineer will lead the design, deployment, and maintenance of secure network access solutions across cloud and on-premises environments. This role focuses on…
Added 5 mins ago
O
Principal Program Manager - OCI Product Marketing
Oracle
Honolulu, HI
- $90,100 to $209,500 USD / year
We are looking for a strategic Program Manager (IC4) to establish and run the operating model for business-critical OCI Web and Oracle AI World programs. This role brings sustained…
Added 5 mins ago
A
Shipyard Project Manager
Aerotek
Honolulu, HI
- $38 to $60 USD / hour
Job Title: Project Manager Pre Planning & Vendor Execution
Added 5 mins ago
Lead Partner Executive
UKG
Honolulu, HI
Program Rollout Success: Evaluate the effectiveness and impact of lead-generating programs rolled out at the field level.
Added 6 mins ago
Group Product Manager, Privacy
Ford Motor Company
Honolulu, HI
As a Group Product Manager, you will lead a small team solving core customer problems. The solutions you help to champion will create an elevated customer experience.
Added 6 mins ago
MI
Full-time Nabisco Merchandiser/Order Writer
Mondelez International
Kaneohe, HI · Honolulu, HI
- $23 USD / hour
- Full-time
Join our Mission to Lead the Future of Snacking AT Mondelēz International
Added 6 mins ago
AT
Senior Technical Program Manager
Akamai Technologies, Inc.
Honolulu, HI
- $119,600 to $215,400 USD / year
As a Senior Technical Program Manager, you will require technical understanding of AI/ML systems, exceptional organizational and program management skills, and proven experience leading…
Added 6 mins ago
USPACOM Group Lead
The MITRE Corporation
Honolulu, HI
The GL is expected to work in partnership with the department manager, and Project Leaders at USPACOM, USARPAC, PACAF, and PACFLT to provide the best “MITRE” staff to related projects and…
Added 6 mins ago
Senior Proposal Manager
Maximus
Honolulu, HI
Maximus is thrilled to announce an opportunity for a Senior Proposal Manager. The primary responsibility of this role is to lead cross‑functional proposal teams, including collaboration…
Added 6 mins ago
Senior Broker Relationship Manager - Small Commercial
Travelers Insurance Company
Honolulu, HI
…employment. As part of our comprehensive compensation and benefits program, employees are also eligible for performance-based cash incentive…
Added 7 mins ago
8L
Manager Trainee- Full Time
84 Lumber Company
Jackson, OH
- Full-time
The Manager Trainee is a full-time, entry-level position designed to prepare you for a leadership role within 84 Lumber. This role offers hands-on training across all aspects of store…
Added 7 mins ago
8L
Entry-Level Manager Trainee (Relocation required after six months in Chandler)
84 Lumber Company
Chandler, AZ
- $16 USD / hour
The Manager Trainee is a full-time, entry-level position designed to prepare you for a leadership role within 84 Lumber. This role offers hands-on training across all aspects of store…
Added 10 mins ago
Sr Program Specialist - Construction, Fire or BAS Background
Honeywell Technologies
Jefferson City, MO
As a Sr. Construction Manager , you will be responsible for overseeing all aspects of multi-year, multisite national programs, managing teams to ensure project schedules, design, execution,…
Added 11 mins ago
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IVF Nurse Manager
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San Francisco, CA
- $135,000 to $165,000 USD / year
The IVF Nurse Manager –provides clinical, operational, and people leadership across all clinical nursing services and patient navigation functions within fertility and specialty care…
Added 12 mins ago
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Compass Group, North America
Joplin, MO
+ Lead the implementation of new menus, products, and culinary initiatives.
Added 14 mins ago
Meeting Manager
BCD
United States
If you love turning complex plans into seamless experiences, this Meeting Manager role might be your sweet spot. You’ll lead meetings and events from kickoff to closeout, partnering with…
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…we can promise a community of people who genuinely care and lead with empathy, a flexible workplace with awesome perks and challenging work that means…
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Director Product Manager, Cloud Infrastructure and AI Networking
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Sunnyvale, CA · Roseville, CA
Lead complex HW and system NPI programs leveraging expertise in HW systems and network ASICs.
Added 16 mins ago
Digital Experience Optimization, Adoption & Effectiveness ( Digital Manager -US)
TD Bank, N.A.
Remote, United States
The Digital Manager manages end to end creation, execution and documentation of long term / multi-year business strategy and roadmaps.
Added 16 mins ago
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Las Vegas, NV
Recruit, train, and lead the sales team, and work cross functionally with other departments
Added 18 mins ago
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Make a Lasting Difference as a Hospice Registered Nurse Case Manager (RNCM)!
Added 20 mins ago
Director of Food Services
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…federal, state, and local standards and regulations. You will lead a team to provide nutritious and appealing meals that enhance the residents’ dining experience and overall quality of…
Added 26 mins ago
G
Architecture Project Manager
GPAC
Grand Rapids, MI
- $90,000 to $110,000 USD / year
Lead Meaningful Projects. Inspire Great Design. Build What's Next.
Added 26 mins ago
G
Architecture Project Manager
GPAC
Warren, MI
- $90,000 to $110,000 USD / year
Lead Meaningful Projects. Inspire Great Design. Build What's Next.

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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