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Medical Device Software Testing Jobs in Texas (NOW HIRING)

Neuralink

Software Design Quality Engineer

Austin, TX · On-site

Own software design control impact assessments for design changes within the medical device design control process; evaluate effects on requirements, architecture, risk controls, verification ...

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 ...

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 ...

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 ...

Actalent

Device Technician

Austin, TX · On-site

$25 - $28/hr

Proficiency with Microsoft Outlook, Teams, Excel, and other standard business software.Ability to ... testing.Experience working in regulated environments such as healthcare, medical device ...

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Medical Device Software Testing information

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.

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.

Medical Device Software Testing jobs near you
Infographic showing various Medical Device Software Testing job openings in Texas as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 14% Part Time, and 6% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution.

Quality Engineer, Software Design Controls

Neuralink

Austin, TX

Full-time

Posted 11 days ago

Job description

Team Description:

Join the Translational Team, where we generate the data that advances Neuralink's brain-computer interface technologies from research and development through clinical evaluation and into market implementation. We produce the rigorous evidence required to support rapid development, regulatory progress, and the safe, effective delivery of the technology to patients.

Job Description and Responsibilities:

The Quality Engineer, Software Design Controls will own software design control strategy, processes, documentation, and continuous improvement across implantable electronics software, surgical robotics software, external systems, and related non-product software. Responsibilities include:

  • Work directly with software and firmware teams to identify design control and software lifecycle risks early, drive robust mitigations, and support design reviews to embed strong design control and IEC 62304 practices.
  • Own software design control impact assessments for design changes within the medical device design control process; evaluate effects on requirements, architecture, risk controls, verification/validation, and traceability; determine re-test, analysis, or documentation needs; and update risk assessments, protocols, and Design History File (DHF) content to maintain ongoing compliance.
  • Own end-to-end software design control strategy and plan/execute activities supporting the full software lifecycle (requirements, architecture, detailed design, implementation, verification, validation, risk management, and release) for Class III and other regulated software in accordance with IEC 62304, ISO 14971, ISO 13485, and related standards.
  • Debug software quality and design control gaps using requirements management tools, traceability matrices, code/architecture reviews, test results, anomaly data, and root-cause analysis techniques; recommend effective process and design mitigations.
  • Develop, execute, and maintain software design control deliverables including design and development plans, software requirements specifications, architecture documents, verification/validation plans and reports, risk management files, traceability matrices, change control records, and requirement-to-test linkages for complex systems involving implants, chargers, robots, and supporting software.
  • Stay current with advancements in medical device software standards, regulatory science, and related technologies; contribute to continuous improvement of compliance processes, SOPs, templates, and knowledge sharing across teams.

Required Qualifications:

  • Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or related technical discipline.
  • 3+ years of hands-on experience with software design controls, software quality, or software design assurance for medical devices.
  • Strong understanding of the software development lifecycle (SDLC) in regulated or safety-critical environments and practical application of design controls.
  • Direct experience planning, executing, reviewing, and documenting software design control and verification/validation activities.
  • Working knowledge of IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk Management), and ISO 13485.
  • Strong cross-functional communication skills and ability to drive issues to closure across engineering, quality, regulatory, and external partners.

Preferred Qualifications:

  • Experience with implants, surgical robotics, wireless systems, or Software as a Medical Device (SaMD) / Software in a Medical Device (SiMD).
  • Prior experience contributing software design control or V&V data to regulatory submissions (IDE, 510(k), PMA, or equivalent) and interfacing with FDA or notified bodies.
  • Experience with medical device design controls, ISO 14971 risk management (including software FMEA / SFMEA), cybersecurity risk assessment, and product development lifecycle in a regulated environment.
  • Experience developing software design control guidelines, training programs, templates, or compliance workflows that accelerate product development.
  • Familiarity with additional standards such as IEC 62366 (usability), 21 CFR Part 11, or cybersecurity guidance (FDA, IEC 81001-5-1).
  • Experience writing test protocols, reports, deviations, engineering rationales, risk assessments, and requirement traceability in a regulated or quality-controlled development process.

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