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Medical Device Validation Engineer Jobs in Georgia

Rambus

Technical Director Validation

Johns Creek, GA · On-site

$160K - $298K/yr

The Technical Director Validation Engineer is a Full-Time position and the candidate will work in ... medical and dental benefits, time-off program, and gym membership. The US salary range for this ...

Avanos Medical

R&D Engineer III

Alpharetta, GA · On-site

Avanos is a medical device company focused on delivering clinically superior breakthrough solutions ... Experience with test method validation, Gage R&R, measurement-system analysis, Design of ...

Rambus

Technical Director Validation

Johns Creek, GA · Hybrid

$160K - $298K/yr

Candidates will be joining some of the brightest inventors and engineers in the world to develop ... medical and dental benefits, time-off program, and gym membership. The US salary range for this ...

Rambus

Technical Director Validation

Johns Creek, GA · Hybrid

$160K - $298K/yr

Candidates will be joining some of the brightest inventors and engineers in the world to develop ... medical and dental benefits, time-off program, and gym membership. The US salary range for this ...

ATL Technology

Application Engineer

Atlanta, GA · On-site

POSITION SUMMARY The Application Engineer serves as a key technical partner to the sales, costing, sourcing, and commercial teams, helping to secure and grow business with our medical device OEM ...

DataSync Inc

Embedded Engineer

Atlanta, GA · On-site

$53 - $54/hr

Embedded Engineer Pay Rate: $53-54/hr on W2 Location: Onsite at Atlanta, GA F2F ... No Duration: 6 months with possible extension Client is a medical device company Strong experience ...

Wise Skulls

Embedded Engineer

Atlanta, GA · On-site

$125K - $165K/yr

Prior experience in medical device product development. * Ability to integrate .NET applications with firmware and hardware components.

Deloitte

System Test and Validation Lead

Atlanta, GA · On-site +1

... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical

Deloitte

System Test and Validation Lead

Atlanta, GA · On-site

... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical

Deloitte

System Test and Validation Lead

Atlanta, GA · On-site +1

... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical

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Showing results 21-40

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Medical Device Validation Engineer information

What does a medical device validation engineer do?

A Medical Device Validation Engineer is responsible for ensuring that medical devices meet regulatory and quality standards before they reach the market. They design and execute tests to validate that products perform as intended, documenting procedures and results to comply with industry regulations such as FDA and ISO guidelines. Their work involves collaborating with design, manufacturing, and quality assurance teams to identify risks and verify that devices are safe and effective for use. This role is crucial for patient safety and for a company's ability to market medical products globally.

What are the key skills and qualifications needed to thrive as a medical device validation engineer?

To thrive as a Medical Device Validation Engineer, you need a strong background in biomedical engineering or a related field, with expertise in validation protocols, regulatory compliance, and risk analysis. Familiarity with technical standards such as ISO 13485, FDA 21 CFR Part 820, and tools like statistical analysis software and validation management systems is essential. Attention to detail, problem-solving abilities, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills are crucial to guarantee that medical devices meet regulatory requirements, function safely, and reach the market efficiently.

What are some common challenges faced by medical device validation engineers during the validation process?

Medical Device Validation Engineers often encounter challenges such as ensuring compliance with evolving regulatory standards, managing tight project timelines, and coordinating cross-functional teams. Additionally, they must address unexpected technical issues that arise during testing and validation, and meticulously document results to meet quality and audit requirements. Effective communication and adaptability are crucial for successfully navigating these challenges and delivering safe, effective medical devices.

What is the difference between Medical Device Validation Engineer vs Quality Assurance Engineer?

AspectMedical Device Validation EngineerQuality Assurance Engineer
CredentialsEngineering degree, certifications like CQE or validation-specific trainingEngineering or related degree, CQE or QA certifications
Work EnvironmentDesign validation, process validation, testing labsAudits, process improvements, compliance documentation
Industry UsageProduct development, validation phases in medical device manufacturingEnsuring overall product quality, compliance, and process control

The Medical Device Validation Engineer focuses on validating medical devices through testing and process validation, ensuring products meet regulatory standards. In contrast, the Quality Assurance Engineer oversees overall quality systems, audits, and compliance processes. Both roles require similar certifications and work within the medical device industry, but their core responsibilities differ in scope and focus.

What are popular job titles related to Medical Device Validation Engineer jobs in Georgia?

For Medical Device Validation Engineer jobs in Georgia, the most frequently searched job titles are:

What job categories do people searching Medical Device Validation Engineer jobs in Georgia look for?

The top searched job categories for Medical Device Validation Engineer jobs in Georgia are:

What cities in Georgia are hiring for Medical Device Validation Engineer jobs?

Cities in Georgia with the most Medical Device Validation Engineer job openings:

    Medical Device Validation Engineer jobs near you
    Infographic showing various Medical Device Validation Engineer job openings in Georgia as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 13% Part Time, and 5% Contract. Highlights an 87% Physical, 1% Hybrid, and 12% Remote job distribution.

    Medical Device Quality Systems & FDA Inspection Readiness Consultant

    The FDA Group

    Atlanta, GA • On-site

    Full-time

    Posted 5 days ago

    Job description

    Medical Device Quality Systems & FDA Inspection Readiness Consultant

    Location: Atlanta/Duluth, Georgia area
    Work Arrangement: Onsite
    Duration: Immediate start through November 2026, with potential extension
    Start: Immediate

    Position Overview

    We are seeking an experienced Medical Device Quality Systems Consultant to provide hands-on support for the startup of a new Class I medical device contract manufacturing operation.

    The consultant will support Quality Management System (QMS) implementation, development of auditable quality and operational processes, system validation, and FDA inspection readiness. A key focus will be ensuring appropriate controls are established across production, warehousing, inventory, traceability, product hold/quarantine, release, and direct-to-consumer distribution activities.

    The engagement will require both quality systems expertise and practical implementation support as the organization works toward regulatory and operational milestones in October and a planned November 1 go-live. The consultant may also provide training and ongoing Quality support following launch.

    Key Responsibilities

    • Review the existing QMS and tailor requirements and processes for the new medical device manufacturing operation.

    • Support implementation of the QMS and ensure processes are operational, documented, and auditable.

    • Develop new quality and operational processes needed to support manufacturing and distribution activities.

    • Support validation of the warehouse management system and associated workflows.

    • Establish and/or assess controls for production, inventory management, product traceability, quarantine/hold, and product release.

    • Develop appropriate quality checks and controls for direct-to-consumer product shipments.

    • Assess Quality System and operational readiness for an anticipated FDA inspection.

    • Identify inspection-readiness gaps and support implementation of corrective actions before go-live.

    • Work directly with facility personnel to operationalize new procedures and quality controls.

    • Provide employee training and implementation support for new or revised processes, as needed.

    • Support the organization through its planned November 1 launch and provide ongoing Quality support following go-live, as needed.

    Required Qualifications

    • Significant medical device Quality or Quality Systems experience.

    • Demonstrated experience implementing or adapting a QMS for medical device operations.

    • Strong knowledge of FDA medical device quality requirements and inspection readiness.

    • Experience developing and implementing auditable quality and operational processes.

    • Experience with warehouse, distribution, inventory, traceability, quarantine/hold, and product release controls.

    • Experience supporting computerized system validation or validation of warehouse/inventory management systems.

    • Ability to provide hands-on implementation support and work directly with site personnel.

    • Ability to work onsite in the Atlanta/Duluth, Georgia area.

    Preferred Qualifications

    • Experience supporting startup or launch activities for a medical device manufacturing operation.

    • Experience with Class I medical devices.

    • Experience establishing quality controls for direct-to-consumer distribution.

    • Local to the Atlanta/Duluth, Georgia area.

    Work Arrangement

    This engagement requires onsite support in the Atlanta/Duluth, Georgia area. Local consultants are preferred to facilitate consistent onsite support.

    Ideal Candidate

    The ideal consultant is a hands-on Medical Device Quality Systems professional with experience taking QMS requirements from documented procedures through practical implementation. The consultant should be comfortable working across quality systems, warehouse and distribution controls, system validation, and FDA inspection readiness while helping a new manufacturing operation prepare for launch.