Apply Now

Validation Engineer

Irvine, CA, US • Posted 60+ days ago • Updated 15 days ago

Full Time

On-site

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

🔢 Crunching numbers...

Job Details

Skills

Cost-benefit Analysis
Budget
Feasibility Study
Presentations
Systems Architecture
Cost Reduction
Testing
Design Review
Research and Development
Forms
Change Control
Management
Regulatory Compliance
Supervision
Electrical Engineering
Mechanical Engineering
Software Engineering
Product Engineering
Manufacturing Engineering
Medical Devices
Process Engineering
Documentation
Continuous Improvement
Collaboration
Project Implementation
Product Design
Electrical Systems
Test Methods
Microsoft Project
Microsoft PowerPoint
Quality Management
Manufacturing

Cost-benefit Analysis
Budget
Feasibility Study
Presentations
Systems Architecture
Cost Reduction
Testing
Design Review
Research and Development
Forms
Change Control
Management
Regulatory Compliance
Supervision
Electrical Engineering
Mechanical Engineering
Software Engineering
Product Engineering
Manufacturing Engineering
Medical Devices
Process Engineering
Documentation
Continuous Improvement
Collaboration
Project Implementation
Product Design
Electrical Systems
Test Methods
Microsoft Project
Microsoft PowerPoint
Quality Management
Manufacturing

Summary

Job Summary:

The Validation Engineer will work under limited supervision to support product validation and engineering activities in a regulated medical device environment. The role focuses on leading Continuous Improvement (CIP) initiatives, supporting process validation, and ensuring compliance with applicable regulatory standards. The engineer will collaborate with internal teams and external suppliers to improve product performance, reduce costs, and ensure robust validation of systems and processes, including those related to product electrical design and functionality.

Roles & Responsibilities:

Lead Continuous Improvement (CIP) projects in collaboration with cross-functional internal teams and external suppliers.
Perform CIP calculations, including supplier quotation evaluations and cost-benefit analysis.
Develop and manage project budgets covering feasibility studies, capital equipment, validation costs, DVT samples, and related testing requirements (e.g., bioburden).
Create detailed project plans using Microsoft Project and prepare presentation materials using PowerPoint.
Demonstrate understanding of product electrical design, system architecture, and functional performance.
Lead design changes, component substitutions, and supplier transitions to achieve cost savings and improved performance (Type II savings).
Develop strategies to meet CIP targets and drive continuous improvement initiatives.
Conduct engineering testing, develop test protocols, prepare test reports, and participate in design reviews.
Oversee project execution including timelines, dependencies, and task coordination.
Identify appropriate electrical test methods and collaborate with R&D teams to align requirements.
Review engineering requirements, support process validation activities, and finalize validation documentation (e.g., RR forms, validation reports).
Execute change control processes and supplier change requests.
Communicate technical issues, risks, and opportunities to management.
Ensure compliance with Health, Safety, Environmental, and regulatory requirements.
Maintain adherence to federal, state, local, and company procedures.
Provide technical guidance or supervision to junior engineers or technicians as needed.

Education & Experience:

Bachelor's degree in Electrical Engineering, Mechanical Engineering, Software Engineering, or related Engineering discipline.
3-5 years of relevant experience in validation engineering, product engineering, or manufacturing engineering within a regulated industry.
Experience in medical device or similarly regulated environments preferred.
Strong understanding of validation processes, process engineering, and engineering documentation.
Experience with Continuous Improvement (CIP), supplier coordination, and project execution is highly desirable.
Familiarity with product design, electrical systems, and engineering test methods is preferred.
Proficiency in Microsoft Project and PowerPoint is an added advantage.
Strong knowledge of regulatory requirements and quality systems in a manufacturing environment.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 724805705b5145e1b9453886acb9d097
Posted 30+ days ago

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Validation Engineer

Irvine, California

•

15d ago

Job summary We are seeking an experienced Validation Engineer to support validation activities, quality systems, and new product development within a regulated medical device environment. The ideal candidate will have hands-on experience with IQ/OQ/PQ, process andequipment validation, verification and validation (V&V), CAPA, root cause analysis,and process improvement. The candidate will collaborate with cross-functional teams and customers to ensure validation activities meet regulatory, quali

Full-time

Engineer II, NPD- Quality

Irvine, California

•

Today

Imagine how your ideas and expertise can change a patient's life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You'll bring your passion for problem solving and partner with various teams to influence decision-making for a product's entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering tec

Full-time

USD 87,000.00 - 123,000.00 per year

Sr Quality Engineer (Automated Equipment)

Irvine, California

•

Today

We are seeking a Senior Quality Engineer to work on a team at our client site in Irvine, CA. The W2 hourly rate range is $55.00 to $59.16 per hour. The role is with Roth Staffing (Ultimate Staffing and Ledgent Tech are divisions of Roth Staffing. No 3rd party candidates can be considered for this role. This Pilot Operations Senior Quality Engineer role partners on the validation activities for an introducer sheath for the Transcatheter Heart Valve (THV) Business Unit. This is a decided proj

Easy Apply

Contract

$55.00 - $59.16 per hour

Sr Quality Engineer

Irvine, California

•

Today

Onsite location: Irvine, CA Pay: $55.00 - $59.00 per hour Job Summary This Pilot Operations Senior Quality Engineer role partners on the validation activities for an introducer sheath for the Transcatheter Heart Valve (THV) Business Unit. Job Description * Our Quality team helps shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. In this role, you will apply your IQ/OQ/PQ knowledge as well a

Easy Apply

Contract

$55.00 - $59.00 per hour

Search all similar jobs

More jobs at Katalyst Healthcares and Lifesciences in Irvine, CA