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Medical Device Software Testing Jobs (NOW HIRING)

Testing & Automation: Drive improvements in software quality by expanding integration testing and ... Background in laboratory equipment, clinical diagnostics, or medical device development.

Ensure compliance with software development and medical device standards, including design controls, risk management, verification and validation, and applicable regulatory frameworks (e.g., IEC ...

iOS Software Engineer (San Diego)

Carlsbad, CA ยท On-site

$110K - $130K/yr

CI/CD pipelines and mobile UI testing (XCUITest) preferred * Experience with medical device software standards (IEC 62304, FDA guidance) preferred Equal Opportunity Employer Carlsmed is an equal ...

iOS Software Engineer (San Diego)

Carlsbad, CA ยท On-site

$110K - $130K/yr

CI/CD pipelines and mobile UI testing (XCUITest) preferred * Experience with medical device software standards (IEC 62304, FDA guidance) preferred Equal Opportunity Employer Carlsmed is an equal ...

Senior Software Engineer

San Diego, CA

$130K - $171K/yr

[Position] Senior Software Engineer [About Our Client] Research & Development hub for artificial ... As medical device development is iterative and subject to regulatory, technical, and business ...

Title : Medical Device Tester II Location : Plano, TX Duration : 6 Months 100% Onsite Position ... Support system-level testing, including firmware/software integration * Ensure compliance with ...

San Diego, CA Length: Long Term. 100% Onsite position Ensure the quality of the medical device software and hardware meets the design requirements Ensure design requirements are testable Develop ...

Senior Software Engineer

San Diego, CA ยท On-site

$130K - $171K/yr

[Position] Senior Software Engineer [About Our Client] Research & Development hub for artificial ... As medical device development is iterative and subject to regulatory, technical, and business ...

CI/CD pipelines and mobile UI testing (XCUITest) preferred * Experience with medical device software standards (IEC 62304, FDA guidance) preferred Equal Opportunity Employer Carlsmed is an equal ...

Senior Software Engineer

San Diego, CA

$130K - $171K/yr

[Position] Senior Software Engineer [About Our Client] Research & Development hub for artificial ... As medical device development is iterative and subject to regulatory, technical, and business ...

Senior Software Engineer

San Diego, CA

$130K - $171K/yr

[Position] Senior Software Engineer [About Our Client] Research & Development hub for artificial ... As medical device development is iterative and subject to regulatory, technical, and business ...

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Perform basic mechanical or electrical testing on assembled components * Inspect parts and finished ... supervisors Medical Device Assembler Qualifications/Requirements: * High school diploma or ...

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Medical Device Software Testing information

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How much do medical device software testing jobs pay per hour?

As of Jun 10, 2026, the average hourly pay for medical device software testing in the United States is $43.50, according to ZipRecruiter salary data. Most workers in this role earn between $33.41 and $52.40 per hour, depending on experience, location, and employer.

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.
More about Medical Device Software Testing jobs
What cities are hiring for Medical Device Software Testing jobs? Cities with the most Medical Device Software Testing job openings:
What states have the most Medical Device Software Testing jobs? States with the most job openings for Medical Device Software Testing jobs include:
Infographic showing various Medical Device Software Testing job openings in the United States as of June 2026, with employment types broken down into 89% Full Time, and 11% Part Time. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution, with an average salary of $90,490 per year, or $43.5 per hour.
Staff Software Engineer

Staff Software Engineer

IT America Inc

Hercules, CA โ€ข On-site

Contractor

PTO

Posted 27 days ago


Job description

Position: Staff Software Engineer

Location: Hercules, California

Duration: Long term contract

Job Description:

As a Staff Software Engineer, you will also provide technical leadership: mentoring junior engineers, driving best practices in code reviews and design discussions, and leading initiatives to modernize our software stack. Youโ€™ll have the opportunity to introduce modern engineering practices (e.g. continuous integration/continuous delivery for embedded, and advanced testing frameworks.) It is hybrid and requires some time in the lab each week. If you are passionate about building high-quality software that has a direct impact on human health, this role offers a unique blend of hands-on development and technical leadership.

How Youโ€™ll Make An Impact:

  • Develop Embedded Control Software: Design and implement the core C++ control software that drives automated lab instruments, handling everything from device initialization to high-level coordination of subsystems to error handling.
  • Orchestration & Scheduling: Develop and maintain scheduling and orchestration logic to coordinate instrument operations (e.g. sample handling, reagent dispensing, measurements) at high throughput (100+ samples/hour). Ensure timed execution of workflows across multiple embedded controllers.
  • Error Handling & Recovery: Build robust error handling and fault recovery mechanisms. Anticipate error conditions (device faults, step loss, etc.) and implement recovery sequences that allow the instrument to safely continue or gracefully halt with minimal downtime.
  • Firmware/Hardware Integration: Interface with distributed firmware microcontroller boards over a CANopen bus (coordinating 10+ boards). Maintain communication protocols and data models for commands/status and ensure reliable real-time messaging between the main software and firmware subsystems.
  • Cross-Functional Collaboration: Work closely with systems engineering to align software with hardware design, with assay scientists to understand requirements, and with quality/regulatory teams to meet compliance and documentation standards. Coordinate integration activities and troubleshooting across mechanical, electronics, and assay domains.
  • Technical Leadership & Mentoring: Mentor junior and mid-level software engineers by sharing best practices in embedded development, performing design and code reviews, and guiding problem solving. Lead architectural discussions and contribute to design documentation for new features and systems.
  • Lab work: Triaging and troubleshooting hardware/software integration issues, and providing expert technical guidance to cross-functional teams.
  • Testing & Automation: Drive improvements in software quality by expanding integration testing and simulation. Lead the development of hardware simulation frameworks and automated test suites to validate instrument behavior in CI/CD pipelines. Champion the use of continuous integration, unit testing, and other modern DevOps practices to increase software reliability and maintainability.

What You Bring:

  • Education & Work Experience: Bachelorโ€™s or masterโ€™s degree in computer science, electrical/computer engineering, related field, or the equivalent experience. Prior experience in an embedded software engineering role designing complex instrument or device software.
  • Embedded C++ Expertise: Extensive experience programming in modern C++ for embedded systems, with a minimum of five years. Strong understanding of object-oriented design, multi-threading, and memory management in constrained environments.
  • RTOS/Embedded Linux Experience: Hands-on experience developing for embedded Linux (e.g., Yocto) or on real-time operating systems (e.g., QNX). Comfortable with low-level OS concepts, device drivers, and optimizing performance on single-board computers.
  • High-Reliability Systems: Proven ability to design software for high uptime and reliability. Experience with fail-safe mechanisms, state machines for complex device control, and graceful degradation of functionality under fault conditions.
  • Testing & CI/CD for Embedded: Familiarity with automated testing frameworks and continuous integration in an embedded context. Experience writing unit and integration tests for embedded code, using hardware-in-loop or simulation, and using CI tools to catch issues early.
  • Collaborative Communication: Excellent cross-functional communication and teamwork skills. Ability to work closely with other engineering disciplines and to clearly articulate technical information to non-software stakeholders.

Preferred Experience

  • Industry Domain: Background in laboratory equipment, clinical diagnostics, or medical device development. Familiarity with the regulatory environment and standards for medical device software (e.g. IEC 62304, ISO 13485) is a plus.
  • Fieldbus Communication: Solid knowledge of industrial communication protocols. Familiarity with CAN/CANopen is a plus โ€“ including defining CANopen object dictionaries, PDO/SDO communication, and network management โ€“ or comparable experience with similar fieldbus protocols (e.g. Modbus, EtherCAT).
  • Legacy System Modernization: Experience modernizing legacy codebase and bringing in contemporary best practices. For example, migrating software to newer C++ standards, refactoring for good architectural patterns, or introducing CI/CD and test automation to legacy embedded projects.
  • Lab Automation & Robotics: Exposure to lab automation robotics, fluidics control, or high-throughput instrumentation. Understanding of timing and scheduling challenges in systems that process many samples in parallel.
  • Simulation and Modeling: Experience with creating simulation models of hardware or using tools to emulate instrument components for testing. This could include using frameworks to simulate sensors/actuators or modeling physical processes to test control algorithms.