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Medical Device Software Jobs in Texas (NOW HIRING)

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 ...

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 ...

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 ...

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Medical Device Software information

See Texas salary details

$19

$46

$90

How much do medical device software jobs pay per hour?

As of Jul 26, 2026, the average hourly pay for medical device software in Texas is $46.43, according to ZipRecruiter salary data. Most workers in this role earn between $32.69 and $55.53 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Medical Device Software Engineer, and why are they important?

To thrive as a Medical Device Software Engineer, you need strong programming abilities (often in C/C++ or Python), a solid understanding of software development life cycles, and familiarity with medical device regulations, typically backed by a degree in computer science, engineering, or a related field. Experience with development tools, embedded systems, and compliance standards like IEC 62304 or FDA requirements is highly valued. Attention to detail, problem-solving, and effective teamwork are essential soft skills in this role. These competencies ensure the creation of reliable, safe, and regulatory-compliant software critical for patient health and device performance.

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

AspectMedical Device SoftwareMedical Device Quality Assurance Specialist
Required CredentialsSoftware development certifications, engineering degrees, FDA regulations knowledgeQuality assurance certifications (e.g., CQE), regulatory compliance training
Work EnvironmentSoftware development teams, R&D labs, regulatory agenciesManufacturing facilities, quality assurance labs, regulatory bodies
Employer & Industry UsageMedical device manufacturers, software firms in healthcareMedical device manufacturers, healthcare companies, regulatory agencies
Common Search & ComparisonFocuses on software development and complianceFocuses on quality processes and regulatory adherence

Medical Device Software professionals develop and maintain software used in medical devices, ensuring functionality and compliance. Medical Device Quality Assurance Specialists focus on testing, validation, and ensuring products meet quality standards. Both roles are essential in the medical device industry but differ in their core responsibilities and skill sets.

What are some common challenges faced by professionals working in Medical Device Software development?

Professionals in Medical Device Software development often navigate complex regulatory requirements, such as FDA or ISO standards, which can impact project timelines and processes. Collaborating closely with cross-functional teams—including hardware engineers, clinicians, and quality assurance specialists—is essential to ensure safety and compliance. Additionally, balancing innovation with rigorous documentation and validation can be challenging, as even minor software changes may require extensive testing and approval. Staying updated with evolving cybersecurity standards is also a key part of the role.

What is medical device software?

Medical device software is specialized software designed to be used for medical purposes, such as diagnosing, preventing, monitoring, or treating health conditions. It can be embedded within a medical device (like a pacemaker) or function as standalone software (such as mobile health apps). This software must comply with strict regulatory standards to ensure safety and effectiveness, as it directly impacts patient health and safety. Developers of medical device software must follow guidelines from authorities like the FDA or EU MDR, depending on the market. Regular updates, risk management, and comprehensive testing are also essential parts of its development process.
Infographic showing various Medical Device Software job openings in Texas as of July 2026, with employment types broken down into 78% Full Time, 14% Part Time, and 8% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $96,577 per year, or $46.4 per hour.
Design Quality Engineer, Software Medical Device

Design Quality Engineer, Software Medical Device

Senseye

Austin, TX • On-site

$100K - $125K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 13 days ago


Job description

About Us
Senseye is a NeuroTechnology Company in Austin, TX on the cusp of revolutionizing Mental Health. Over the past 6 years we have invested millions of dollars in R&D to build our platform allowing us to measure cognitive activity via the eye through mobile phones. Through multiple iterations and use cases we are now focused on building the world's first Objective Mental Health Diagnostics on top of our core technology. Our first diagnostic is for PTSD and is entering clinical trials now, followed soon by additional indications for Anxiety and Depression. As the world struggles with a mental health crisis, it is not hyperbolic to suggest that an objective diagnostic platform, that gives clinicians a safe and objective accurate approach to identifying and monitoring mental health disease, will redefine how mental health services are provided and will enable access to treatment for hundreds of millions of sufferers. The Senseye platform has the potential to be the technology that drives this change.
Senseye is developing AI-enabled software medical devices to help make mental health assessment more objective, starting with PTSD. We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner closely with engineering, clinical, regulatory, and product teams to build practical, audit-ready quality processes for SaMD development.
Role Description
This is a hands-on role for someone who understands design controls, software lifecycle documentation, risk management, and regulated product development - and who wants to help shape the quality system rather than simply maintain one. This is an intersection role: it requires both medical-device design-controls/quality experience and hands-on software / SaMD lifecycle experience - not one or the other.
Requirements
This role requires both of the following, not either/or:
  • 4+ years in medical-device design quality, design assurance, or quality engineering for regulated software (design controls + software lifecycle).
  • 2+ years hands-on with SaMD, SiMD, or medical-device software (including digital health / diagnostics software).
  • Hands-on experience with design controls, risk management, software validation, traceability, and quality-system documentation.
  • Working knowledge of ISO 13485, ISO 14971, IEC 62304, FDA QMSR / 21 CFR Part 820, and 21 CFR Part 11.
  • Comfort working directly with software teams using tools such as Jira, GitHub, Confluence, and eQMS systems.

Responsibilities
  • Own and improve SaMD design-control deliverables, including user needs, design inputs/outputs, traceability, design reviews, verification/validation evidence, and DHF readiness.
  • Partner with software, data science, clinical, and regulatory teams to apply IEC 62304, ISO 14971, ISO 13485:2016, FDA QMSR / 21 CFR Part 820, and applicable software quality practices.
  • Support AI/ML model lifecycle quality practices, including documentation, risk controls, change control, validation evidence, and total-product-lifecycle thinking.
  • Help define pragmatic QMS processes for a fast-moving regulated startup, including software development, non-product software validation / CSA, supplier controls, CAPA, and audit readiness.
  • Contribute to cybersecurity, usability/HFE, post-market, complaint, and quality-metrics activities in partnership with subject-matter experts
Nice to Have
  • AI/ML-enabled medical-device experience.
  • Familiarity with IMDRF GMLP principles.
  • Cybersecurity documentation experience for medical devices.
  • Usability / human factors engineering experience.
  • FDA submission, audit, notified-body, CAPA, or post-market experience.
  • Experience in a startup or early-stage regulated product environment.

Why this role is compelling
You will help shape the quality foundation for an AI-enabled SaMD product, not just maintain inherited procedures.
  • You will work cross-functionally with engineering, clinical, regulatory, product, and data science teams.
  • You will have direct impact on design controls, software lifecycle quality, risk management, and audit readiness.
  • You will join at a stage where quality decisions still materially shape how the product and QMS scale.

Benefits
  • The freedom and trust to define your role as we design, build, and ship our products
  • Competitive salary and stock option plan
  • Flexible paid time off (vacation, sick leave, and public holidays)
  • Flexible schedules
  • Company health care plan
    • Medical, dental, and vision insurance
    • Short and long term disability insurance
    • Life insurance policy
  • 401k
  • Commuter benefits for parking, public transit, carshares, etc.
  • Mothers' room
  • Fully stocked kitchen
  • Opportunities for continuing education

The compensation for this role is $100,000 - $125,000 annually.
Senseye is dedicated to building a community of employees that are diverse, passionate, and engaged. We are committed to equal opportunity regardless of race, color, ancestry, religion, gender, gender identity, parental or pregnancy status, national origin, sexual orientation, age, marital status, disability, or veteran status. When we're safe, healthy, and balanced we can accomplish phenomenal things together.

Senseye logo

About Senseye

Sourced by ZipRecruiter

Industry

Scientific research and development services

Company size

11 - 50 Employees

Headquarters location

Austin, TX, US

Year founded

2015

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