Senior R&D Project Engineer

Karwell Technologies

Irvine, CA

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JOB DETAILS

SKILLS

Biomedical Engineering, Budget Management, Budgeting, Calendar Management, Change Control, Change Management, Communication Skills, Corporate Compliance, Cost Control, Cross-Functional, Documentation, Engineering, FDA Requirements, Feasibility Analysis, Healthcare Quality, Investment Capital, Leadership, Maintain Compliance, Manufacturing Engineering, Manufacturing Requirements, Mechanical Engineering, Medical Equipment, Medical Products, Medical Protocols, Microsoft Project, Multitasking, Process Validation, Product Control, Product Development, Product Lifecycle Management, Project Development, Project Engineering, Project Execution, Project Planning, Project Schedule, Project/Program Management, Quality Engineering, Regulations, Regulatory Compliance, Regulatory Requirements, Research & Development (R&D), Risk Analysis, Risk Management, Schedule Development, Supply Chain, Team Player, Test Plan/Schedule, Testing, Validation Documentation, Validation Testing, Vendor/Supplier Evaluation, Vendor/Supplier Management

LOCATION

Irvine, CA

POSTED

1 day ago

Job Description:

We are seeking a highly motivated Senior R&D Project Engineer to lead Cost Improvement Projects (CIP), design changes, supplier change initiatives, and product lifecycle management activities within a regulated medical device environment.
The ideal candidate will possess strong project management skills, medical device product development experience, regulatory knowledge, and the ability to collaborate effectively with cross-functional teams and external suppliers.
This role will drive engineering projects from concept through implementation while ensuring compliance with quality and regulatory requirements.

Roles & Responsibilities:

Lead Cost Improvement Projects (CIP) by coordinating activities across internal teams, suppliers, and stakeholders.
Develop project budgets by evaluating supplier quotations, feasibility studies, capital investments, validation activities, DVT samples, and bioburden requirements.
Create and manage project plans, schedules, timelines, and deliverables using Microsoft Project.
Lead design change, supplier change, and alternative sourcing projects to achieve cost savings and business objectives.
Perform engineering testing, protocol development, test execution, and preparation of technical reports.
Conduct design reviews and collaborate with R&D, Quality, Regulatory Affairs, Manufacturing, and Supply Chain teams.
Develop and execute verification and validation activities in accordance with regulatory requirements.
Support process validation, risk assessments, and product change control activities.
Review and finalize validation documentation, risk management files, and regulatory documentation.
Manage engineering change requests and supplier change requests through completion.
Provide project updates, presentations, and recommendations to senior management.
Ensure compliance with company quality systems, FDA regulations, and international medical device standards.
Drive project execution while managing scope, risks, timelines, and budgets.

Requirements:

Bachelor's degree in mechanical engineering, Biomedical Engineering, Manufacturing Engineering, or related discipline.
Minimum 6+ years of experience in Medical Device Product Development, R&D Engineering, Sustaining Engineering, or Project Engineering.
Experience leading engineering projects in regulated medical device environments.
Strong understanding of FDA regulations and medical device quality systems.
Experience managing supplier change, design change, and cost improvement projects.
Experience creating project plans and schedules using Microsoft Project.
Strong communication, leadership, and stakeholder management skills.
Ability to work independently and manage multiple projects simultaneously.

About the Company

Karwell Technologies

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