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Medical Device Software Testing Jobs in Texas (NOW HIRING)

Synkriom

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Technical Recruiter -Medical device

Austin, TX · On-site

$40 - $41/hr

As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a ... Familiarity with applicant tracking systems and other HR software. Company Description Founded in ...

USA Firmware

Principal Embedded Firmware Engineer

Houston, TX · On-site

$98K - $134K/yr

This role focuses on Class I, II, and III medical devices, including neuromodulation platforms ... device drivers, testing, integration, and verification * Familiarity with software development ...

USA Firmware

Principal Embedded Firmware Engineer

Houston, TX · On-site

$98K - $134K/yr

This role focuses on Class I, II, and III medical devices, including neuromodulation platforms ... device drivers, testing, integration, and verification * Familiarity with software development ...

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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.
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 86% Full Time, and 14% Part Time. Highlights an 100% In-person job distribution.

Embedded Tester ||Frisco, TX

McKinsol Consulting Inc

Frisco, TX • On-site

Other

Posted 18 days ago

Job description

Embedded Tester
Frisco, TX
Mandatory Skills
Perform software code regression analysis (in C & C++) with knowledge of custom HW design to plan for Verification testing. Experience in C/C++ coding is must. Good experience and understanding of Medical Quality Management System(MQMS) ISO 13485, Risk Management ISO 14971, Medical Device-SDLC-IEC 62304 is preferred
Strong experience in Embedded Device Manual Software Verification .
Expertise in understanding the System and Software architecture, Test protocols, debugging and test execution.
Experience in Test protocol design , review and update
Hands-on work experience in communication protocols and thorough understanding of communication protocols like UART, SPI, I2C, BLE, NFC, USB, etc.,
Expertise in testing software from inception, requirement specifications, planning, designing, test protocols development, configuration, release management, defect identification, prevention, root cause analysis & documentation to Final release.
Strong experience in Design Verification Testing.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Experience in working for regulated industry like Medical, Aero, Auto
Strong experience in handling the test equipment like Oscilloscope, Function generators, DMM, PSU.

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