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Medical Device Software Testing Jobs (NOW HIRING)

Abbott

Software Quality Engineer

Alameda, CA · On-site

$80 - $85/hr

... Testing experience. * Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has ... Medical Device experience strongly preferred. * Cybersecurity, medical web and mobile applications ...

1 point system

R&D Engineer Sr.

Alameda, CA · On-site

$100K - $136K/yr

... and maintenance of medical device software. Coordinate activities with other engineering ... or Software Testing. Knowledge of FDA QSR, relevant ISO guidelines, and 21 CFR Part 11. Has ...

Alcon

Principal, Software Engineer

Lake Forest, CA · On-site

$143K - $192K/yr

The Principal Software Engineer, Medical Device Systems is responsible for maintaining, enhancing ... Provide inputs for scope, impact, and effective test methodologies for testing. * Assure compliance ...

Brooksource

Software Quality Engineer

Indianapolis, IN · On-site

$55 - $64/hr

Support the design, development, and testing of medical device software, including Software as a Medical Device (SaMD) products * Provide leadership, guidance, and expertise on software development ...

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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 Sep 1, 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 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.

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:

Medical Device Software Testing jobs near you
Infographic showing various Medical Device Software Testing job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 15% Part Time, and 7% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $90,490 per year, or $43.5 per hour.

Senior Firmware Test Engineer

Tactile Medical

Minneapolis, MN • On-site

Full-time

Posted 7 days ago

Tactile Medical rating

8.6

Company rating: 8.6 out of 10

Based on 11 frontline employees who took The Breakroom Quiz

Job description

Position Summary

At Tactile Medical, we develop at-home therapy devices that help patients manage chronic health conditions. The Senior Firmware Test Engineer applies deep firmware and device software test experience to help ensure regulated medical device products are safe, reliable, and ready for release. This position partners closely with firmware engineers to verify embedded software behavior and connected-device workflows across firmware, mobile, and cloud touchpoints. It strengthens how firmware and device software are tested by shaping practical test approaches, building automated coverage, supporting verification evidence, and helping engineering teams resolve complex issues before they reach patients or customers.

Responsibilities
  • Plan and lead execution of risk-based firmware and device software testing for regulated medical device products.
  • Develop and maintain automated tests, test tools, scripts, fixtures, and repeatable test environments that improve coverage, consistency, and execution efficiency.
  • Create and maintain clear verification documentation, including test protocols, test cases, traceability, objective evidence, results summaries, and release-supporting records.
  • Support software verification activities in alignment with IEC 62304, ISO 14971, design controls, requirements management, and regulated software documentation practices.
  • Collaborate with firmware, mobile, and cloud engineering teams to test Bluetooth and Wi-Fi connectivity using mobile devices, including provisioning, connection reliability, data exchange, and connected device workflows.
  • Drive defect investigation by reproducing issues, analyzing logs and device behavior, supporting root cause analysis, and communicating test findings to engineering partners.
  • Strengthen firmware test practices through test reviews, mentoring, automation improvements, documentation discipline, and coordination with internal and offshore contributors.
Required Qualifications
  • Bachelor's degree in Computer Engineering, Computer Science, or a related technical discipline.
  • 7+ years of progressive experience testing firmware, embedded software, device software, or software-controlled products, including ownership of complex test areas.
  • Strong ability to design test approaches, develop automated tests or scripts, analyze test results, and improve repeatability across firmware and device test environments.
  • Hands-on regulated medical device software verification experience, including creation or review of test protocols, test cases, traceability, objective evidence, and release documentation.
  • Working knowledge of IEC 62304, ISO 14971, design controls, requirements management, software verification, and regulated product development documentation.
Preferred Qualifications
  • Connected medical device experience involving firmware-controlled devices, diagnostics, provisioning, telemetry, secure updates, manufacturing test, service tools, or post-market support.
  • Depth testing connected devices that use wired or wireless communication technologies, such as Bluetooth, Wi-Fi, or device-to-device communication.
  • Automated test framework, hardware-in-the-loop, simulator, test fixture, CI/CD, regression test, or lab automation design and maintenance background.
  • Mobile/cloud integration testing background across edge-to-cloud workflows, connected-device data flows, cybersecurity testing, secure update behavior, or vulnerability verification.
  • Familiarity with SBOM/SOUP concepts, medical device cybersecurity guidance, or FDA 510(k) software documentation support.

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