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Medical Device Validation Engineer Jobs in Dallas, TX

Required * BS in Engineering (Chemical preferred), life sciences or related field. * 3+ years of validation work experience in a pharmaceutical and/or medical device industry. * Certified Quality ...

Required * BS in Engineering (Chemical preferred), life sciences or related field. * 3+ years of validation work experience in a pharmaceutical and/or medical device industry. * Certified Quality ...

... validation testing, risk assessment and production tooling validation. * Applies statistical ... Applies knowledge of materials and manufacturing methods for medical devices * Generate detailed ...

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Medical Device Validation Engineer information

See Dallas, TX salary details

$22

$51

$77

How much do medical device validation engineer jobs pay per hour?

As of Aug 31, 2026, the average hourly pay for medical device validation engineer in Dallas, TX is $51.44, according to ZipRecruiter salary data. Most workers in this role earn between $38.99 and $62.55 per hour, depending on experience, location, and employer.

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 Dallas, TX?

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

What job categories do people searching Medical Device Validation Engineer jobs in Dallas, TX look for?

The top searched job categories for Medical Device Validation Engineer jobs in Dallas, TX are:

What cities near Dallas, TX are hiring for Medical Device Validation Engineer jobs?

Cities near Dallas, TX with the most Medical Device Validation Engineer job openings:

Validation Engineer

Fort Worth, TX โ€ข On-site

Contractor

Re-posted 21 days ago


Job description

Job Title: Validation Engineer

Location: Fort Worth, TX (Local candidates only)

Travel: Required – Alabama (3–4 weeks, expenses paid)

Duration: 3–6 Month Contract

Start Date: Immediate

Job Summary

We are seeking a Validation Engineer to support EO sterilization validation activities within a regulated manufacturing environment. This role will focus on supervising and coordinating Performance Qualification (PQ) execution activities while ensuring compliance with GMP and ALCOA+ documentation standards.

The ideal candidate will have hands-on experience with sterilization validation processes, strong coordination skills, and the ability to support cross-functional execution activities in a fast-paced environment.

Key Responsibilities

  • Supervise execution of EO sterilization Performance Qualification (PQ) activities
  • Coordinate half-cycle, nominal/full-cycle, and maximum-cycle sterilization runs
  • Prepare and manage PCDs (Process Challenge Devices) and Biological Indicators (BIs) for shipment and cycle insertion
  • Support preparation and arrangement of dunnage for EO sterilization processes
  • Oversee movement of product loads through refrigerated storage, tempering, sterilization, and aeration processes
  • Coordinate retrieval and shipment of PCDs, BIs, and product samples for Quality Control testing
  • Ensure execution activities and documentation comply with ALCOA+ principles and GMP requirements
  • Collaborate with Validation, Quality, and Operations teams to support project timelines and execution

Required Qualifications

  • Experience in validation within medical device, pharmaceutical, or regulated manufacturing environments
  • Hands-on knowledge of EO sterilization validation and PQ execution activities
  • Strong understanding of GMP documentation practices and ALCOA+ principles
  • Ability to coordinate cross-functional activities and manage execution timelines
  • Strong communication and organizational skills