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Added 2 mins ago
CO
Utilities Analyst I
City of Anaheim
Anaheim, CA
- $37.58 to $56.37 USD / hour
Working closely with the Utilities Warehouse & Logistics Manager, the Utilities Analyst I will help ensure that the materials and equipment APU depends on are planned for, ordered, and…
Added 14 mins ago
Senior Product Manager, AI/ML
Google
Sunnyvale, CA · New York, NY
5 years of experience working cross-functionally with engineering, UX/UI, sales finance, and other stakeholders.
Added 14 mins ago
Technical Program Manager, Neutral Atoms, Quantum AI
Google
Boulder, CO
As a Technical Program Manager for the Quantum AI team, you usher complex, multi-disciplinary quantum computing projects through the entire project lifecycle using your engineering…
Added 19 mins ago
M
Principal Product Manager
Microsoft
WA · CA · Redmond, WA · Mountain View, CA · Redmond · Mountain View
- $142,800 to $304,200 USD / year
⚡ Fast-paced execution across multiple engineering organizations
Added 20 mins ago
M
Principal Technical Program Manager
Microsoft
United States
- $142,800 to $304,200 USD / year
We are looking for a Principal Technical Program Manager to connect enterprise customer needs, field insights, and engineering execution across Microsoft's security portfolio. You will lead…
Added 20 mins ago
M
Senior Hardware Engineer
Microsoft
WA · CA · OR · Redmond, WA · Mountain View, CA · Hillsboro, OR · Redmond · Mountain View · Hillsboro
- $119,800 to $261,000 USD / year
The SPPO (SCHIE Product and Procurement Optimization) team is seeking a Senior Hardware Engineer, Technical Program Manager to drive complex hardware initiatives. This role requires a…
Added 27 mins ago
G
Mechanical Project Manager
GPAC
Sioux City, IA
- $90,000 to $140,000 USD / year
The Project Manager is responsible for leading mechanical construction projects from preconstruction through closeout. This role requires strong leadership, financial oversight, scheduling…
Added 27 mins ago
G
Mechanical Project Manager
GPAC
Des Moines, IA
- $90,000 to $140,000 USD / year
The Project Manager is responsible for leading mechanical construction projects from preconstruction through closeout. This role requires strong leadership, financial oversight, scheduling…
Added 28 mins ago
G
Mechanical Project Manager
GPAC
Waukesha, WI
- $90,000 to $140,000 USD / year
The Project Manager is responsible for leading mechanical construction projects from preconstruction through closeout. This role requires strong leadership, financial oversight, scheduling…
Added 28 mins ago
G
Mechanical Project Manager
GPAC
Green Bay, WI
- $90,000 to $140,000 USD / year
The Project Manager is responsible for leading mechanical construction projects from preconstruction through closeout. This role requires strong leadership, financial oversight, scheduling…
Added 28 mins ago
G
Mechanical Project Manager
GPAC
Racine, WI
- $90,000 to $140,000 USD / year
The Project Manager is responsible for leading mechanical construction projects from preconstruction through closeout. This role requires strong leadership, financial oversight, scheduling…
Added 28 mins ago
G
Mechanical Project Manager
GPAC
Kenosha, WI
- $90,000 to $140,000 USD / year
The Project Manager is responsible for leading mechanical construction projects from preconstruction through closeout. This role requires strong leadership, financial oversight, scheduling…
Added 28 mins ago
G
Mechanical Project Manager
GPAC
Eau Claire, WI
- $90,000 to $140,000 USD / year
The Project Manager is responsible for leading mechanical construction projects from preconstruction through closeout. This role requires strong leadership, financial oversight, scheduling…
Added 28 mins ago
G
Mechanical Project Manager
GPAC
Appleton, WI
- $90,000 to $140,000 USD / year
The Project Manager is responsible for leading mechanical construction projects from preconstruction through closeout. This role requires strong leadership, financial oversight, scheduling…
Added 28 mins ago
G
Mechanical Project Manager
GPAC
Madison, WI
- $90,000 to $140,000 USD / year
The Project Manager is responsible for leading mechanical construction projects from preconstruction through closeout. This role requires strong leadership, financial oversight, scheduling…
Added 34 mins ago
Technical Project Manager III
Blue Origin LLC
Kent, WA
…status, risks & opportunities, variances, and recovery plans to engineering and program management. You will be hands on with the team supporting the week-to-week planning and execution.…
Added 36 mins ago
Senior Product Manager, Product Systems
Agoda
Chicago, IL
…build products from conception to launch by bringing together engineering and business worlds. Rocket Travel's Product Managers work closely with executive leadership and have high…
Added 37 mins ago
Sr. Technical Product Manager
Keysight Technologies, Inc.
Calabasas, CA · Santa Clara, CA
Keysight is seeking a Senior Technical Product Manager to engage hyperscalers, network equipment manufacturers (NEMs), silicon vendors, and AI data center operators on the validation of…
Added 40 mins ago
C
Program Manager, EBMS
CBRE
Columbus, OH
- $105,000 to $115,000 USD / year
…(EBMS) to support our client’s Global Realty Building Design &Engineering. The candidate will be responsible for managing several workstreamsto improve BMS Delivery and align with our…
Added 40 mins ago
Agile Product Owner
Trinzic
Beavercreek Township, OH
…government stakeholders, systems engineers, architects, and software development teams, translating complex mission and engineering requirements into actionable product backlogs that drive…
Added 40 mins ago
Materials & Equipment Coordinator
The Davey Tree Expert Company
Richfield, OH
…entry-level position will report to the Materials & Equipment Manager but will also work closely with our operations managers to ensure that materials and equipment needs match the required…
Added 40 mins ago
Mechanical Engineer - Heat and CBRN
Hunter Defense Technologies Inc
Geneva, OH
…heaters. Working under the guidance of senior engineers and the Engineering Manager, this role supports ongoing product development, prototype fabrication, system troubleshooting, and…
Added 40 mins ago
Technical Delivery Manager - Digital Engineering
CVS Health
Remote, United States
In this role, you will be working across multiple engineering teams to drive the delivery of our digital products focused on helping people live healthier lives. As a Technical Delivery…
Added 41 mins ago
Sr. Manager Data Science
Scotts Miracle-Gro
Marysville, OH
Added 41 mins ago
Senior Remote Services Engineer
Honeywell Technologies
Independence, OH
…support and services to our customers. You will leverage your engineering expertise to troubleshoot, resolve complex issues, and optimize system performance, ensuring customer satisfaction…

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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