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Added 1 min ago
Head Universal Banker - Hoboken Branch
Citi
HOBOKEN, NJ · Hoboken, NJ · Hoboken
Champion risk and control by monitoring day-to-day operations, ensuring compliance with policies, supporting the Branch Manager
Added 2 mins ago
SI
SAP Success Plan Manager – Specialist - NEC
SAP IT Business Systeme
Newtown Square, PA
- $107,300 to $230,600 USD / year
Clear, effective communication, translating technical progress into business language and keeping stakeholders informed under uncertainty.
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Bedford, MA
Master's or Doctorate Degree in a related field and at least 20 years of experience in the respective technical / professional discipline being performed, 12 years of which must be in the…
Added 3 mins ago
Sr Project Manager – Strategic Implementations QNXT
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Hartford, CT
…higher levels, incumbents manage large multifaceted projects. Technical partnership and cross collaboration within a matrixed organization is a daily…
Added 3 mins ago
CH
Pharmacy Technician
CVS Health
Minneapolis, MN
- $18.37 to $28.37 USD / hour
Once in role, Technicians are required to complete a rigorous company training program and satisfy all registration, licensing, and certification requirements according to their State’s…
Added 4 mins ago
Master Stylist
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Bend, OR
…emphasis on the guest’s total look. They support the Experience Manager (SM) and Assistant Services Manager (ASM) through a focus on performance (service sales, and productivity), people…
Added 9 mins ago
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Automation Chemist - Chemspeed
Bruker Nano Inc
Boston, MA
- $78,000 USD / year
…Automation Chemist into positions like Business Development Manager, Project Manager, Workflow…
Added 9 mins ago
TL
Technical Account Manager - Marketing Solutions
TransUnion LLC
Chicago, IL · NY · Reston, VA
- $82,700 to $120,000 USD / year
This role reports directly to the Senior Manager of the Technical Account Management division.
Added 12 mins ago
Design - Architect II / III / Senior
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Burlington, MA
Assess the requirements of a project, break a project into tasks, and work with a Project Manager to determine scope of work, budget and staffing.
Added 14 mins ago
Partner Director, Palo Alto Networks
Carousel Industries
Boston, MA
- Serve as the central relationship manager for Palo Alto Networks' field, channel, and regional organizations.
Added 15 mins ago
Head Universal Banker - Hoboken Branch
Citibank, N.A.
United States
Champion risk and control by monitoring day-to-day operations, ensuring compliance with policies, supporting the Branch Manager
Added 16 mins ago
Program Manager/Coordinator [P1ACBRNP010]
ProSidian Consulting, LLC
Jefferson County, AR
We seek Program Manager/Coordinator candidates with relevant DOD/Military Sector Experience (functional and technical area expertise also ideal) to support professional services engagement…
Added 16 mins ago
Deputy Program Manager And Supply Chain Lead
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Jefferson County, AR
Deputy Program Manager and Supply Chain Lead | P1ACBRNP011
Added 16 mins ago
Data And Reporting Analyst
ProSidian Consulting, LLC
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Coordinate with the Program Manager and the property management, Item Unique Identification (IUID), procurement, quality, and IT teams.
Added 16 mins ago
Government-Directed Members and Cognizant Authority Affected Leads.
ProSidian Consulting, LLC
Jefferson County, AR
Coordinate with the Contracting Officer (CO), Contracting Officer’s Representative (COR), Joint Program Manager (JPM), cognizant engineering authority, and Pine Bluff Arsenal (PBA).
Added 16 mins ago
Logistics Manager Functional Lead And Coordinator
ProSidian Consulting, LLC
Jefferson County, AR
Coordinate with Operations, Warehouse, the Program Manager, and the Pine Bluff Arsenal (PBA) receiving team.
Added 16 mins ago
Packaging And Transportation
ProSidian Consulting, LLC
Jefferson County, AR
Service alignment - NAICS 541611, Management and Financial Consulting, Acquisition and Grants Management Support, and Business Program and Project Management Services.
Added 16 mins ago
Quality And Configuration Lead
ProSidian Consulting, LLC
Jefferson County, AR
Service alignment - NAICS 541611, Management and Financial Consulting, Acquisition and Grants Management Support, and Business Program and Project Management Services.
Added 16 mins ago
Quality Assurance Manager
ProSidian Consulting, LLC
Jefferson County, AR
ProSidian seeks a Quality Assurance Manager to lead quality management, maintain audit readiness, and drive continuous improvement for CP DEPMEDS. The role supports materiel readiness,…
Added 16 mins ago
Quality Assurance Manager
ProSidian Consulting, LLC
Jefferson County, AR
Coordinate with the Program Manager, Quality and Configuration Lead, suppliers, and the Pine Bluff Arsenal (PBA) receiving team.
Added 16 mins ago
Warehouse And Kit Lead
ProSidian Consulting, LLC
Jefferson County, AR
Service alignment - NAICS 541611, Management and Financial Consulting, Acquisition and Grants Management Support, and Business Program and Project Management Services.
Added 16 mins ago
Risk Control Consultant Boiler and Machinery - Little Rock, AR
Military Spouse Jobs & VetJobs
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…employment. As part of our comprehensive compensation and benefits program, employees are also eligible for performance-based cash incentive…
Added 16 mins ago
Logistics Technical Planner/ Integrator - Washington DC
Military Spouse Jobs & VetJobs
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Markon is seeking an experienced Logistics Technical Planner/Integrator to support an Intelligence Community customer. This role will provide strategic logistics planning, process…
Added 18 mins ago
Staff Process Engineer, Drive Unit (3rd Shift)
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Added 18 mins ago
C
Project Lead
CRH
Littleton, CO
- $75,000 to $85,000 USD / year
…the process, and acts to problem solve proactively, offers technical advice, and assists other staff to expedite assigned projects, removes obstacles which may cause a project to fall…

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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