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Medical Device Software Testing Jobs in Texas (NOW HIRING)

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 ...

IQVIA

MedTech Device Software Support

Dallas, TX · On-site

Our Technical Support Representative opportunity would see you supporting a leading medical device manufacturer's software update needs on equipment based in hospitals, pharmacies and other clinical ...

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 ...

DMS Vision Inc.

Embedded Tester -SIT (Onsite)

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 ...

New

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 ...

Spectral MD Inc

Software Engineer

Dallas, TX · On-site

Experience in medical device software development * Familiarity with regulated software ... testing, protected veteran status, or any other characteristic protected by applicable federal ...

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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 Design Control Engineer

Software Design Control Engineer

Neuralink

Austin, TX • On-site

$71K - $119K/yr

Full-time

Medical, Dental, Vision, Retirement

Posted 5 days ago

Job description

About Neuralink:
We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.
Team Description:
Join the Quality Systems Team, where our mission is to ensure compliance with applicable regulatory standards by designing scalable, efficient, and automation-driven systems. We focus on embedding compliance directly into engineering workflows rather than treating it as a manual or reactive function.
We are a team of industry-experienced professionals who apply systems thinking and creative problem-solving to build a durable compliance infrastructure that supports rapid development. Our vision is to establish internal design and quality systems that exceed FDA expectations while enabling fast iteration and deployment of complex, safety-critical software products.
Job Description and Responsibilities:
Please note, this is a duplicate posting for the "Quality Systems Engineer" role. We are testing titling to see which attracts the most qualified candidates. Please only apply to one of the postings.
As a Software Design Controls Engineer, your primary responsibility will be to design, implement, and continuously improve software-focused design control systems with regulatory compliance embedded into their architecture.
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 lifecycle, from requirements definition through verification, validation, risk management, and release.
You will continuously optimize these systems to improve speed, traceability, and audit readiness while supporting aggressive development timelines and frequent design changes. Your responsibilities include, but are not limited to:
  • Design and implement scalable software design controls systems aligned with IEC 62304 and FDA design control requirements (21 CFR 820.30)
  • Develop and maintain end-to-end traceability frameworks linking:
    • User needs
    • Software requirements
    • Risk controls
    • Design outputs (code, architecture)
    • Verification and validation evidence
  • Integrate software risk management into design controls, ensuring alignment with ISO 14971 principles
  • Build change control mechanisms capable of supporting:
    • Rapid iteration
    • Parallel development
    • Same-day deployment
  • Partner closely with software engineering teams to embed:
    • Compliance with CI/CD pipelines
    • Automated evidence generation
    • Controlled release processes
  • Own subsets of the Quality System related to software design controls, including but not limited to:
    • Software Design Control processes
    • Software Risk Management
    • Software Change Control
    • Software Verification & Validation traceability

Required Qualifications:
  • Bachelor's degree in Electrical Engineering, Computer Science, or a related technical field
  • Demonstrated experience designing or maintaining structured engineering or compliance systems
  • Familiarity with software development lifecycles in regulated or safety-critical environments
  • Working knowledge of:
    • Design Controls
    • Software requirements management
    • Proficiency in basic scripting, automation, or querying (e.g., Python, SQL, or equivalent)
  • Excellent written and verbal communication skills
  • Strong problem-solving mindset with the ability to think in systems rather than silos

Preferred Qualifications:
  • Familiarity with IEC 62304 (Medical Device Software Lifecycle Processes)
  • Familiarity with FDA Design Controls (21 CFR 820.30)
  • Familiarity with Design Risk Management (ISO 14971 principles)
  • 1-3 years of experience in:
    • Software Design Controls Engineer
    • Software Quality
    • Regulated software development

Expected Compensation:
The anticipated base salary for this position is expected to be within the following range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. We also believe in aligning our employees' success with the company's long-term growth. As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees.
Base Salary Range:
$71,000-$119,000 USD
What We Offer:
Full-time employees are eligible for the following benefits listed below.
  • An opportunity to change the world and work with some of the smartest and most talented experts from different fields
  • Growth potential; we rapidly advance team members who have an outsized impact
  • Excellent medical, dental, and vision insurance through a PPO plan
  • Paid holidays
  • Commuter benefits
  • Meals provided
  • Equity (RSUs) *Temporary Employees & Interns excluded
  • 401(k) plan *Interns initially excluded until they work 1,000 hours
  • Parental leave *Temporary Employees & Interns excluded
  • Flexible time off *Temporary Employees & Interns excluded

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