Jobs in the United States

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Added 2 mins ago
Systems Engineer I
Panasonic
De Soto, KS
Do you want to join a team that's changing the world? Do you have a strong background as a Systems Engineer I? Then we're looking for you! Check out the job description and apply now! Put…
Added 8 mins ago
GH
Senior Software Engineer
GE Healthcare IITS USA Corp.
Remote, United States
- $109,600 to $164,400 USD / year
As a Senior Software Engineer in GE HealthCare's Science & Technology organization, you will develop scalable, cloud-based software solutions that support healthcare innovation and digital…
Added 9 mins ago
Senior Systems Engineer - MANTIS SEIT (Onsite)
RTX
United States
Qualifications You Must Have
Added 9 mins ago
Principal Radar / RF Electrical Subsystems Engineer
RTX
United States
Qualifications You Must Have:
Added 9 mins ago
Software Engineering Intern (Summer 2027)
RTX
United States
Qualifications You Must Have
Added 15 mins ago
Design Engineering Manager
The businesses of Merck KGaA, Darmstadt, Germany
Austin, TX
…support new product development, configure-to-order (CTO), engineer-to-order (ETO), and product sustaining…
Added 15 mins ago
Design Engineering Manager
The businesses of Merck KGaA, Darmstadt, Germany
Chandler, AZ
…support new product development, configure-to-order (CTO), engineer-to-order (ETO), and product sustaining…
Added 17 mins ago
Systems Development Engineer, Amazon Leo - OISL
Amazon Kuiper Manufacturing Enterprises LLC
Redmond, WA
We're looking for a hands-on Systems Engineer with a background in the requirements management, design for manufacturing, hardware/software development for hardware test.
Added 18 mins ago
Test Engineer II
Sierra Nevada Corporation
Sparks, NV
Qualifications You Must Have:
Added 19 mins ago
AI Engineer – Generative AI & Agentic AI
KData Inc.
United States
The AI Engineer works closely with AI Architects, software engineers, data
Added 19 mins ago
Senior Engineer - PLC/Ignition
E Tech Group
South San Francisco, CA · Vacaville, CA
We are seeking an Senior Automation Engineer to contribute to detailed hardware and software design of process automation control systems projects. This includes a combination of…
Added 21 mins ago
O
Principal Software Engineer, Core Infrastructure
Oracle
Seattle, WA · Santa Clara, CA
- $114,600 to $234,600 USD / year
Leads development and begins architecting components of scalable, elastic distributed systems. Defines and enforces scalability requirements for owned components; optimizes code and data…
Added 24 mins ago
Product Engineer, Agents & Harnesses
Engram Lab
San Francisco, CA
…workflows and solving the last-mile problems that arise when our systems meet real data, code, and…
Added 27 mins ago
Test Engineer 3
Flextronics America, LLC
TX
Performing hands-on debugging, validation, and system-level failure analysis of next-generation server and rack systems within a high-mix, high-ambiguity manufacturing environment.
Added 28 mins ago
Systems Engineer
BAE Systems
Nashua, NH · Manchester, NH
Job Description Thank you for your interest in BAE Systems! Are you a Systems Engineer with 2 to 20+ years of experience looking for the next step to grow your career? Do you want to…
Added 28 mins ago
Machine Learning Ops, AI Engineer
Mission Underwriting Services
Remote, United States
…responsiveness, and eliminates the burden of outdated legacy…
Added 30 mins ago
Senior Windows System Engineer
HP
Spring, TX · Palo Alto, CA
This role is responsible for overseeing the design, implementation, and maintenance of robust and scalable software systems for HP commercial PCs. The role collaborates with…
Added 30 mins ago
EP
Senior Fleet Engineer [Hybrid]
EDF power solutions
Bloomington, MN
- $107,200 to $178,600 USD / year
Demonstrated expertise in lithium-ion battery systems and battery management systems (BMS), including battery operation and performance, cell monitoring, state-of-charge and state-of-health…
Added 40 mins ago
Engineering Systems Administrator (SolidWorks)
LeeBoy Inc
Lincolnton, NC
The SolidWorks Administrator / CAD Systems Engineer is responsible for the administration, optimization and continuous improvement of the organization's SolidWorks and Enterprise PDM (SPDM)…
Added 43 mins ago
Artificial Intelligence/Machine Learning 2
Wyetech
Annapolis Junction, MD
Artificial Intelligence/Machine Learning (AI/ML) Engineer Skill Level 2
Added 46 mins ago
Senior Data & AI Engineer
NeoReach
Remote, United States
The Senior Data & AI Engineer will connect business systems, improve data quality, and develop reliable tools that help teams work efficiently and make better decisions.
Added 47 mins ago
Test Engineer 2
Lam Research
Fremont
‘Virtual Flex’ you’ll work 1-2 days per week on-site at a Lam or customer/supplier location, and remotely the rest of the time
Added 52 mins ago
ST
Senior Scientist, In Vitro Efficacy
Scribe Therapeutics
Alameda, CA
- $150,000 to $180,000 USD / year
…Scientist I/II, In Vitro Efficacy to advance our ongoing efforts to engineer highly active and specific CRISPR enzymes. The successful candidate will serve as the analytical lead…
Added 53 mins ago
Staff SW QA Engineer
Dexcom
Remote, United States
You will drive organizational improvements related to software quality systems, development practices, automation, verification, validation, and compliance processes.
Added 55 mins ago
L
Senior Hardware/Software Integration Engineer
Lightship
South San Francisco, CA
- $160,000 to $180,000 USD / year
As a Senior Hardware/Software Integration Engineer, you will work hands-on with vehicle hardware and software to bring new components and features to life, troubleshoot complex issues, and…

Oracle

Principal Technical Learning Consultant - SaMD Product Development & QA

Jefferson City, MO, United States

Apply on hiremo.mo.gov About employer

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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...

Apply on hiremo.mo.gov About employer

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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Work requirements

Jobs in the United States