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Added 2 mins ago
Advanced Operations Engineer
Waseyabek Development Company
Otsego, MI
Added 3 mins ago
Senior Quality Engineer - Aerospace & Defense Manufacturing
Moseley Technical Services, Inc.
Lapeer, MI
Sr Quality Engineer Aerospace & Defense Manufacturing Lapeer, MI $90,000 - $120,000/Yearly U.S. Citizenship is required by Federal Law We are hiring a Senior Quality Engineer to lead…
Added 3 mins ago
Ford Racing Product Development Engineer
Ford Motor Company
Allen Park, MI
…are looking for a talented and highly motivated Body Exterior Engineer to join our Body Exterior Engineering…
Added 3 mins ago
SIOP Manager - Pneumatics Platform
IDEX
Benton Harbor, MI
…Linthicum, Maryland, we offer the scale and agility to innovate, engineer, and transform ideas into reliable solutions for the world’s most critical applications. Our products power…
Added 3 mins ago
Mechanical Engineer
Eotech, Inc.
Plymouth, MI
Mechanical Engineer # Mechanical Engineer Plymouth, MI 48170 Apply Apply ## Description POSITION DESCRIPTION P osition Title: Mechanical Engineer Department: Product Development…
Added 3 mins ago
Electrical Hardware Engineer
SL America Corporation
Auburn Hills, MI
…Statements of Requirements (SOR) to evaluate technical feasibility, product performance requirements, and validation strategies. Perform electromagnetic and thermal simulations using ANSYS…
Added 3 mins ago
Program Engineer
SL America Corporation
Auburn Hills, MI
Implement exterior automotive lighting product development projects from concept design through production launch. Design and develop mechanical systems, structures, and components for…
Added 3 mins ago
Electrical Technician II
ROUSH
Livonia, MI
At Roush, we fuse technology and engineering to provide product development solutions to customers in a diverse range of industries. Widely recognized for providing engineering, testing,…
Added 3 mins ago
Lead Mechanical Design Engineer-High Voltage Connector
Eaton Corporation
Southfield, MI
Eaton’s Power Connections business is seeking a Lead High Voltage Connector Mechanical Design Engineer to develop high-voltage automotive connection systems from concept through production.…
Added 3 mins ago
Software Engineer Lead
Michigan State University Federal Credit Union
East Lansing, MI
Description The Software Engineering Lead is responsible for the design, development, implementation, and lifecycle ownership of MSUFCU's portfolio of software solutions. This can include…
Added 3 mins ago
Senior Software Engineer
Ford Motor Company
Dearborn, MI
Senior Software Engineer - positions offered by Ford Motor Company (Dearborn, Michigan). Note, this is a purely telecommuting/work-from-home position whereby the employee may reside…
Added 3 mins ago
Senior Full Stack Software Engineer – AI/ML
HTC Global Services Inc
Dearborn, MI
We are seeking a Senior Full Stack Software Engineer with experience in building, developing, and deploying scalable software applications and AI-powered solutions. The ideal candidate will…
Added 3 mins ago
Senior Mobile Software Engineer – iOS (Swift) / Android (Kotlin)
HTC Global Services Inc
Dearborn, MI
We are seeking an experienced Senior Mobile Software Engineer with strong hands-on expertise in native iOS and Android application development. The ideal candidate will have extensive…
Added 3 mins ago
Blue Cruise Core Integration Engineer
Ford Motor Company
Dearborn, MI
We bring engineering ideas to life. In Product Development, we make driving more exciting, enjoyable and sustainable. Ford’s Advanced Driver Assistance Systems (ADAS) team designs and…
Added 3 mins ago
Senior Lead Engineer
PwC
Detroit, MI · Grand Rapids, MI
As a Senior Lead Engineer you will lead custom application development and testing efforts that help clients turn business needs into scalable software solutions across cloud-native and…
Added 3 mins ago
Supplier Quality Engineer - Airfoil Castings
GE Aerospace
Detroit, MI
The Supplier Quality Engineer will drive quality for assigned suppliers, including quality plan implementation, & selecting suppliers through qualification processes. They will own supplier…
Added 3 mins ago
Senior Engineer
PwC
Detroit, MI · Grand Rapids, MI
As a Senior Engineer you will help design, build, and test custom applications within our Advisory practice, bringing together software engineering, cloud-based solution delivery, and…
Added 3 mins ago
Front End Web Applications Developer (Mid-Level) (5664)
SMX
Lansing, MI
SMX is currently looking for a highly motivated Software Engineer - Front End Web Applications to contribute to the design, build, support, and implementation of the Budget and Spend (BAS)…
Added 3 mins ago
Front End Web Applications Developer (Junior) (5660)
SMX
Lansing, MI
SMX is currently looking for a highly motivated Software Engineer - Front End Web Application s to contribute to the design, build, support, and implementation of the Budget and Spend (BAS)…
Added 3 mins ago
Associate Software Engineer
Highmark Health
Lansing, MI
This job is an integral member of an agile software engineer team responsible for building scalable software applications across all digital channels to serve our customers. Responsible for…
Added 3 mins ago
Director - Customer Response Engineering
Trellix
Lansing, MI
Partner with Technical Support, Customer Success, Product Management, and Engineering so issues reach the right engineer fast and customer feedback reaches the roadmap.
Added 3 mins ago
Vice President, Cloud Platform Engineer
SitusAMC
Lansing, MI
SitusAMC is on a Digital Transformation journey to Strategize, implement, and automate end-to-end product delivery using turn-key technologies. This role requires a passion for programming…
Added 3 mins ago
EG
Senior Full Stack Developer
Eliassen Group
Farmington Hills, MI
- $60 to $70 USD / hour
…& Asset Management solutions. The role focuses on frontend development, backend services, integrations, cloud-native applications, and production support in a collaborative…
Added 9 mins ago
J
Senior Software Back End Engineer
Jobgether
Remote, United States
- $122,275 to $165,431 USD / year
…steps. Our partner is looking for a Senior Software Back End Engineer based in the United…
Added 13 mins ago
Staff Mobile Engineer - Promo
Hard Rock Digital
Remote, United States
We’re looking for a Staff Mobile Engineer to own technical direction for mobile experiences within the Promos domain, working within our shared React Native platform and contributing to…

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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