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Medical Device Software Testing Jobs in Texas (NOW HIRING)

Zimmer, Inc.

Software Quality Manager

Austin, TX

Proficiency in Verification & Validation (V&V), Design Controls, Software Testing (SDLC), and Hardware Testing, Solid understanding of Medical Device in Design Control * Experience in drafting formal ...

Vytwo

Bioinformatics Pipeline Test Engineer

Prosper, TX · On-site

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 ...

Neuralink

Software Design Control Engineer

Austin, TX · On-site

We are testing titling to see which attracts the most qualified candidates. Please only apply to ... regulated medical device software. These systems will support the full software lifecycle, from ...

Smith & Nephew

Software Validation Engineer 2

Austin, TX · On-site

$70K - $105K/yr

Review and approve software validation documentation for both medical and non-medical device ... validation and testing activities. * Mechanical, Chemical or Biomedical Engineering degree ...

Neuralink

Software Design Control Engineer

Austin, TX · 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 ...

Spectral MD Inc

Cybersecurity Engineer

Dallas, TX · On-site

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

Noblesoft Technologies

Embedded Tester

Frisco, TX · On-site

... 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 ...

Astura Medical

Medical Device Audit Inspector

Irving, TX · 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 ...

Astura Medical

Medical Device Audit Inspector

Irving, TX · 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 ...

Neuralink

Quality Systems Engineer

Austin, TX

You will build systems that eliminate ambiguity, reduce manual effort, and enable rapid and reliable development of regulated medical device software. These systems will support the full software ...

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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, and why are they important?

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.
What are popular job titles related to Medical Device Software Testing jobs in Texas? For Medical Device Software Testing jobs in Texas, the most frequently searched job titles are:
What job categories do people searching Medical Device Software Testing jobs in Texas look for? The top searched job categories for Medical Device Software Testing jobs in Texas are:
Medical Device Software Testing jobs near you
Infographic showing various Medical Device Software Testing job openings in Texas as of July 2026, with employment types broken down into 84% Full Time, 8% Part Time, and 8% Contract. Highlights an 100% In-person job distribution.

Software Quality Manager

Zimmer, Inc.

Austin, TX

Other

Posted 14 days ago

Job description

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.


What You Can Expect

Manage software testing teams for manual & automated testing and analysis to identify defects, verify software requirements and prepare documents based on the company QMS(Quality Management System) and regulatory environment, and provide leadership to Software Test Engineers.

How You'll Create Impact

Essential Responsiblities:

  • Manage SW verification and Software release strategy based on the USA FDA, European and Asia Pacific in a regulatory environment
  • Provide leadership and supervision to testing teams on multiple projects, mentor, and manage a team of SW Test engineers onshore & offshore, overseeing daily operations, workload prioritization
  • Plan schedules for formal cycle testing
  • Guide test teams to prepare & execute test cases (manual / automated), prepare test plans and test protocols.
  • Submit defects reports using defect tracking application and follow through on its resolution
  • Prepare weekly test metrics and present report to SW director on a regular basis
  • Participate in Defect Review Board and work with Software Quality Engineer to follow up on features & defects Ability to travel is required
  • Verify all software systems comply US FDA's 21 CFR Part 820 (QMSR) and IEC 62304 (Medical Device Software Lifecycle Processes)
  • Collaborate with Software Development Team & Software Quality Assurance teams to follow the company Quality procedures
  • Prepare Delivery of Software Master Test Plans, Test Protocols per formal testing cycles
  • Ensure Testing cycles are executed on timely manners with sufficient resources
  • Provide Support post-market for installation
  • Continuous execution of Dry Run testing
  • Support internal & external audit when required
  • Support Manual Testing when required Verify traceability matrices linking user needs requirements, System Design specifications, and test cases
  • Liaison between Software Development team, Software Quality Assurance team
  • Collaborate with DevOps and Software Development teams to integrate manual and automated test suites into CI/CD pipelines while ensuring compliance with FDA and IEC 62304 requirements
  • Familiarity with Test management tool such as Jira, Jama or equivalent and automation frame works
What Makes You Stand Out
  • Deep understanding of FDA, ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management), IEC 62304 (Software Lifecycle), Cybersecurity (ANSI/AAMI SW96, IEC 81001-5-1, NIST), and EU MDR, Software in and Software as a Medical Device (SiMD/SaMD)
Your Background
  • Minimum of Bachelor's degree in Biomedical or Mechatronics or Computer Engineering, or a related field
  • 5-8+ years of software testing experience, with at least 4+ years in a Lead or Managerial role within the medical device or a regulated industry.
  • Has lead group of test engineers on multiple projects simultaneously
  • Proficiency in Verification & Validation (V&V), Design Controls, Software Testing (SDLC), and Hardware Testing, Solid understanding of Medical Device in Design Control
  • Experience in drafting formal requirements
  • Solid understanding Risk Assessment & Mitigation process
  • Proficiency in written and spoken English
Physical Requirements
Travel Expectations

15-20%


EOE/M/F/Vet/Disability

Employment Type: OTHER

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