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Medical Device Validation Engineer Jobs in Texas

Texas Instruments

Validation Engineer NCG

Dallas, TX · On-site

Device debug As a Validation Engineer, you will also get exposure to each of these roles through formal learning, projects and on-the-job development experiences that will help you broaden your ...

Crown Medical, Inc.

Medical Device Rep

Austin, TX · On-site

$82K - $113K/yr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... Have a valid driver's license * At least some success with abilities in business-to-business sales;

Stark Pharma Solutions Inc

CQV Engineer

Austin, TX · On-site

CQV Engineer Location: Austin, TX Duration: Long Term Position Overview We are seeking an ... and Validation (CQV) activities for pharmaceutical and medical device manufacturing facilities.

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Medical Device Validation Engineer information

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 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.

Are medical device validation engineers in demand?

Medical device validation engineers are in high demand due to the increasing regulation and complexity of medical devices. They play a critical role in ensuring compliance with standards like ISO 13485 and FDA requirements, and their expertise in validation, testing, and quality assurance is sought after in the healthcare industry.

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 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 popular job titles related to Medical Device Validation Engineer jobs in Texas? For Medical Device Validation Engineer jobs in Texas, the most frequently searched job titles are:
What job categories do people searching Medical Device Validation Engineer jobs in Texas look for? The top searched job categories for Medical Device Validation Engineer jobs in Texas are:
What cities in Texas are hiring for Medical Device Validation Engineer jobs? Cities in Texas 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 Texas as of July 2026, with employment types broken down into 76% Full Time, 16% Part Time, and 8% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution.

Medical Device Verification & Validation Engineer

Stark Pharma Solutions Inc

San Antonio, TX • On-site

Contractor

Posted 13 days ago

Job description

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Medical Device V&V Engineer position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Position: Medical Device Verification & Validation Engineer

Location: San Antonio, TX (100% Onsite)
Duration: 12+ Month Contract
 

Job Overview

We are seeking a Medical Device Verification & Validation Engineer to support new product development and sustaining engineering initiatives. The ideal candidate will have strong experience in mechanical verification and validation, protocol development, statistical analysis, and testing of sterile medical devices within a regulated environment.

Key Responsibilities

  • Support cross-functional teams throughout new product development and sustaining engineering activities.
  • Develop, execute, and document Design Verification & Validation (V&V) protocols and reports.
  • Perform functional, performance, packaging, and reliability testing for medical devices.
  • Analyze test data using Minitab and other statistical tools to support product verification.
  • Conduct product stability and shelf-life testing for sterile medical devices.
  • Own V&V documentation within the Design History File (DHF).
  • Ensure compliance with design controls, FDA regulations, and applicable industry standards.
  • Collaborate with global engineering, quality, and operations teams to standardize verification methods and testing procedures.
  • Manage multiple projects while supporting timely product development milestones.

Required Qualifications

  • Bachelor's degree in Mechanical Engineering or related discipline.
  • 4+ years of Verification & Validation experience within the Medical Device industry.
  • Hands-on experience with Design Verification & Validation activities, including protocol development, execution, and reporting.
  • Strong experience using Minitab or other statistical analysis software.
  • Knowledge of product stability testing and shelf-life validation for sterile medical devices.
  • Experience working on new product development (NPD) and cross-functional engineering teams.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.  

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com