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Medical Device Software Testing Jobs in Texas (NOW HIRING)

... medical device. * Identify the relevant test hardware equipments'''' for the system testing ... Develop software integration test plan and protocols against design input docs & code for embedded ...

Familiar with automated software testing, preferably in the context of medical devices software ... Familiarity with medical device requirements such as Quality System Regulation (21 CFR part 820 ...

Software Design Control Engineer

Austin, TX ยท On-site

$71K - $119K/yr

We are testing titling to see which attracts the most qualified candidates. Please only apply to ... Familiarity with IEC 62304 (Medical Device Software Lifecycle Processes) * Familiarity with FDA ...

... secure medical device software systems, ensuring that cybersecurity controls are resilient and ... Cybersecurity requirements, testing, and traceability matrices in alignment with FDA guidance and ...

... medical device. Identify the relevant test hardware equipments' for the system testing. Develop software integration test plan and protocols against design input docs & code for embedded handheld ...

New

Associate Software Engineer

Irving, TX ยท On-site +1

$50K - $101K/yr

What You'll Do If hired, you will help develop innovative medical device software solutions. You'll ... Evaluate software designs through testing and documentation. * Collaborate with cross-functional ...

New

Associate Software Engineer

Irving, TX ยท On-site

$50K - $101K/yr

What You'll Do If hired, you will help develop innovative medical device software solutions. You'll ... Evaluate software designs through testing and documentation. * Collaborate with cross-functional ...

... medical device. Identify the relevant test hardware equipments' for the system testing. Develop software integration test plan and protocols against design input docs & code for embedded handheld ...

Medical Device Audit Inspector

Irving, TX ยท On-site

$20 - $21/hr

As a Medical Device Audit Inspector, you will support various inventory activities within the ... Creating nonconforming and discrepancy reports using ERP software * Cleaning of incoming surgical ...

Associate Software Engineer

Irving, TX ยท On-site +1

$50K - $101K/yr

What You'll Do If hired, you will help develop innovative medical device software solutions. You'll ... Evaluate software designs through testing and documentation. * Collaborate with cross-functional ...

Medical Device Audit Inspector

Irving, TX ยท On-site

$20 - $21/hr

Creating nonconforming and discrepancy reports using ERP software * Cleaning of incoming surgical ... Familiarity with medical device handling, sterilization, or reprocessing workflows * Strong ...

Medical Device Audit Inspector

Irving, TX ยท On-site

$20 - $21/hr

Creating nonconforming and discrepancy reports using ERP software * Cleaning of incoming surgical ... Familiarity with medical device handling, sterilization, or reprocessing workflows * Strong ...

... medical device. * Identify the relevant test hardware equipments'' for the system testing. * Develop software integration test plan and protocols against design input docs & code for embedded ...

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Medical Device Software Testing information

What is the difference between Medical Device Software Testing vs Medical Device Quality Assurance?

AspectMedical Device Software TestingMedical Device Quality Assurance
CertificationsISTQB, CSTE, or similar testing certificationsISO 13485, CAPA, or quality management certifications
Work EnvironmentTesting labs, development teams, regulated environmentsQuality management systems, compliance departments
Employer & Industry UsageMedical device companies, software developersManufacturers, regulatory agencies, compliance firms
Search & Comparison IntentUnderstanding testing roles, skills, and responsibilitiesUnderstanding quality assurance processes, compliance standards

Medical Device Software Testing focuses on verifying and validating software functionalities to ensure safety and compliance. Medical Device Quality Assurance encompasses broader quality management practices, including process audits and compliance to standards. Both roles are essential in the medical device industry but serve different purposes in ensuring product safety and regulatory adherence.

What is medical device software testing?

Medical device software testing is the process of verifying and validating the software used in medical devices to ensure it is safe, reliable, and compliant with regulatory standards. This involves various testing methods, such as functional, performance, and usability testing, to identify and fix potential issues before the device is released to the market. Proper software testing helps prevent device failures that could harm patients and ensures that the device operates as intended under all expected conditions.

What are the key skills and qualifications needed to thrive as a medical device software tester?

To excel as a Medical Device Software Tester, you need a strong background in software testing methodologies, knowledge of regulatory standards like IEC 62304, and a degree in computer science or engineering. Familiarity with testing tools such as Selenium, Jira, and automated test frameworks, as well as experience with validation and verification documentation, is typically required. Attention to detail, analytical thinking, and effective communication are crucial soft skills that help testers identify issues and collaborate with cross-functional teams. These skills and qualifications are vital to ensure the safety, reliability, and compliance of medical device software in a highly regulated industry.

What are some common challenges faced by professionals in medical device software testing, and how can they be addressed?

Professionals in medical device software testing often encounter challenges such as ensuring compliance with strict regulatory standards (like FDA or ISO 13485), managing complex documentation requirements, and keeping up with frequent software updates. Addressing these challenges requires a strong focus on detail, thorough understanding of relevant regulations, and effective communication with development and quality assurance teams. Collaborating closely with cross-functional teams and maintaining up-to-date knowledge of regulatory changes are key to successfully navigating these demands.
Infographic showing various Medical Device Software Testing job openings in Texas as of August 2026, with employment types broken down into 86% Full Time, and 14% Part Time. Highlights an 100% In-person job distribution.