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Validation Engineer

Round Lake, IL, US • Posted 2 days ago • Updated 12 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Regulatory Compliance
Test Plans
Testing
Issue Resolution
Collaboration
Research and Development
Manufacturing
Systems Engineering
Risk Management
System Requirements
Design Review
Electromechanics
Verification And Validation
Design Controls
Quality Management
Communication
Documentation
ISO 13485
Medical Devices

Summary

Job Summary:

We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products.
The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements.
Experience with infusion pump systems or similar electromechanical medical devices is preferred.

Roles & Responsibilities:

Plan and execute system-level Verification & Validation (V&V) activities for medical device products.
Develop, review, and execute validation protocols, test plans, and test reports.
Perform validation testing, document results, investigate failures, and support issue resolution.
Ensure validation activities comply with applicable quality standards, regulatory requirements, and internal procedures.
Collaborate with cross-functional teams including R&D, Quality, Regulatory, Manufacturing, and Systems Engineering.
Support design verification, risk management, and product validation efforts.
Maintain accurate documentation in accordance with FDA, ISO 13485, and company quality system requirements.
Participate in design reviews and provide technical input related to system validation.

Education & Experience:

Bachelor's degree in Engineering or a related technical discipline.
Minimum 10 years of Validation Engineering experience.
Strong experience in the Medical Device industry, preferably with infusion pumps or similar electromechanical medical devices.
Hands-on experience with System-Level Verification & Validation (V&V).
Proven experience executing validation protocols, documenting results, and resolving validation issues.
Strong understanding of design controls, validation processes, and quality systems.
Excellent communication and documentation skills.
Preferred: Experience working with FDA-regulated medical devices.
Preferred: Knowledge of ISO 13485, 21 CFR Part 820, IEC 60601, and related medical device standards.
Preferred: Previous experience with client or other leading medical device manufacturers.

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: a54ca3d6200aef9f009c60b2e274b876
Posted 2 days ago

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