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Added 3 mins ago
Principal AI Solutions Architect, Customer Success
United States - Genesys Cloud Services, Inc.
Virtual Office, TX · IN · SC · TN · FL · MA · NC · KY · GA
…partner directly with C-suite executives, business leaders, and technical stakeholders to define enterprise AI strategies, architect scalable solutions, and guide customers from AI…
Added 3 mins ago
PN
Human Resources Strategic Partner
Pacific Northwest National Laboratory
Richland, WA
- $117,900 USD / year
Added 4 mins ago
Self-Checkout Attendant
Festival Foods
De Pere, WI
…and efficient checkout process. This role involves providing technical support, troubleshooting issues, and enhancing the overall shopping experience. The attendant maintains a clean and…
Added 6 mins ago
G
Program Manager
GPAC
Torrington, CT
- $85,000 to $130,000 USD / year
A plastics/medical device manufacturer is hiring a Program Manager to lead customer programs from concept through commercialization in a regulated life sciences and interventional medical…
Added 9 mins ago
CO
Tree Inspector
City of Portland
Portland, OR
- $40.91 to $52.21 USD / hour
Provide technical program and arboricultural expertise through clear and detailed written responses to diverse stakeholders.
Added 13 mins ago
Patient Services Representative, Greenville OB/GYN, FT, Days
Prisma Health-University Medical Group
Greenville, SC
…phone support as needed and outlined through cross training program. Screens visitors and responds to routine requests for information. Responsible for gathering, accurately coding and…
Added 14 mins ago
MI
Engineering Manager
Moog Inc
Salt Lake City, UT
- $145,000 to $180,000 USD / year
Our Defense team in Salt Lake City, UT, is eagerly looking for an Engineering Manager to join their dynamic team. The Site Engineering Manager will lead a multidisciplinary team of…
Added 16 mins ago
Warehouse Manager
Mercana
Newport News, VA
The Warehouse Manager is accountable for the full operation of the Newport News site - receiving, put-away, storage, picking, packing, shipping, dropship, inventory control, and the…
Added 19 mins ago
CO
Economic Development Director (Unclassified) (Mayor’s Office)
City of San Jose
San Jose, CA
- $170,000 to $215,000 USD / year
…under the City Charter, is responsible for recommending policy, program, and budget priorities for the City. The Mayor and Council are responsible for representing the residents of San…
Added 19 mins ago
T
Lead Java Practice Architect
TEKsystems
Hanover, MD
- $160,000 to $225,000 USD / year
Owns technical direction and outcomes for a program or domain, driving clarity and decisions in ambiguous situations
Added 19 mins ago
T
Senior Data And AI Project Manager
TEKsystems
Boston, MA
- $90 to $110 USD / hour
Strong project, program, and portfolio management leadership skills.
Added 26 mins ago
Plant Manager
Trident Seafoods Corporation
Bellingham, WA
Leads daily operations for the Alaska Naturals facility, including production, technical processes, maintenance coordination, quality, safety, staffing, and site administration.
Added 30 mins ago
UG
Behavioral Intake Counselor
UnitedHealth Group
San Diego, CA
- $24 to $43 USD / hour
Elevate operational issues/ concerns to supervisor or manager
Added 30 mins ago
UG
Behavioral Intake Counselor
UnitedHealth Group
San Diego, CA
- $24 to $43 USD / hour
Elevate operational issues/ concerns to supervisor or manager
Added 33 mins ago
Technical Assistance & Research Center Associate
United States
The TARC Associate supports both technical assistance and research across NCUIH public health programs. The position helps Urban Indian Organizations (UIOs) implement training and…
Added 34 mins ago
Senior Compliance Manager
Kastel Staffing
Los Angeles, CA
…training rollout, and stand up the subcontractor/vendor monitoring program (background check attestations, disclosure sheets, spot-check…
Added 34 mins ago
Product Manager
Kastel Staffing
Huntsville, AL
As a Product Manager you will have a critical role in setting the long-term vision and strategy for our company’s products. You will work closely with our engineers, executives, business…
Added 35 mins ago
KC
Capital Project Manager III
King County
Seattle, WA
- $121,042.27 to $153,428.08 USD / year
…your community and King County partners. The Capital Project Manager III works with internal and external teams to prepare, manage and review a variety of high-visibility…
Added 35 mins ago
KC
Lead Mechanic
King County
Renton, WA · Maple Valley, WA
- $47.01 to $59.59 USD / hour
…develop the next generation of mechanics through coaching and technical…
Added 37 mins ago
SO
Project Manager II - Director of Workforce Wellbeing
State of Mississippi
Hinds County, MS
- $56,345.82 to $84,603.26 USD / year
Eligible employees have the opportunity to participate in the state’s health and prescription insurance program. Employees may select either single or family coverage with affordable…
Added 37 mins ago
SO
CORR-CASE MANAGER II (DUAL ROLES)- CMCF CLASSIFICATION
State of Mississippi
Rankin County, MS
- $44,788.15 USD / year
Eligible employees have the opportunity to participate in the state’s health and prescription insurance program. Employees may select either single or family coverage with affordable…
Added 39 mins ago
Sr. Facilities Service Manager, Data Center - Electrical (M3)
Oracle
Jefferson City, MO
+ Serve as the direct manager for Electrical Facilities Technicians, providing day-to-day leadership, work prioritization, coaching, performance management, and technical development.
Added 43 mins ago
Project Engineer - Mission Critical
The Bowa Group Inc
Dallas, TX
The Project Engineer supports the Project Manager, Superintendent, and project team in the technical and administrative execution of a hyperscale data center project. This field-based role…
Added 43 mins ago
VDC Engineer - Mission Critical
The Bowa Group Inc
Dallas, TX
The VDC Project Engineer will report to the VDC Senior Project Manager and support the implementation and execution of BIM and VDC processes across large-scale construction projects. This…
Added 44 mins ago
R
Manager, Account Executive, Strategic
Ramp
Remote, United States
- $580,000 to $620,000 USD / year
As a Manager of Strategic Account Executives at Ramp, you'll lead the team responsible for winning our largest and most complex customers. Reporting to our Enterprise Sales Leader, you'll…

Oracle

Principal Technical Learning Consultant - 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, safety, cyb...

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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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