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Medical Device Software Testing Jobs (NOW HIRING)

Zimmer, Inc.

Software Quality Manager

Austin, TX

Proficiency in Verification & Validation (V&V), Design Controls, Software Testing (SDLC), and Hardware Testing, Solid understanding of Medical Device in Design Control * Experience in drafting formal ...

Abbott

Software Compliance Engineer

Alameda, CA

Must have 1 - 3 years project experience in software testing practices, methodologies including ... Medical Device experience strongly preferred. * Cybersecurity, medical mobile applications or cloud ...

Abbott

Software Compliance Engineer

Alameda, CA · On-site

Must have 1 - 3 years project experience in software testing practices, methodologies including ... Medical Device experience strongly preferred. * Cybersecurity, medical mobile applications or cloud ...

Abbott

Software Compliance Engineer

Alameda, CA · On-site

Must have 1 - 3 years project experience in software testing practices, methodologies including ... Medical Device experience strongly preferred. * Cybersecurity, medical mobile applications or cloud ...

eNGINE LLC

Embedded Systems QA Engineer

Pittsburgh, PA · On-site

$122K - $161K/yr

Perform testing on safety-critical medical device software and associated applications * Develop and maintain automated test scripts using tools and scripting languages such as Python and Bash

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Medical Device Software Testing information

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$19

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$69

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

As of Jun 9, 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.
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What cities are hiring for Medical Device Software Testing jobs? Cities with the most Medical Device Software Testing job openings:
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What job categories do people searching Medical Device Software Testing jobs look for? The top searched job categories for Medical Device Software Testing jobs are:
Medical Device Software Testing jobs near you
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.
Principal Software Test Engineer - 2 Openings

Principal Software Test Engineer - 2 Openings

DivIHN Integration Inc

Plymouth, MN • On-site

$142K - $191K/yr

Contractor

Posted 8 days ago

Job description

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

Visit us at https://divihn.com/find-a-job/ to learn more and view our open positions.

 
Please apply or call one of us to learn more

For further inquiries about this opportunity, please contact one of our Talent Specialists, Hema, at (630) 847-0275 or Sri Balan, at (630) 847-0953
Title: Principal Software Test Engineer - 2 Openings
Duration: 6 Months (Temp. to Perm.)
Location: Plymouth, MN

Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.

Job Description
The Principal Software Test Engineer leads the design, development, and execution of the software testing strategy for complex medical device systems. This role is responsible for ensuring that all software whether embedded, application level, algorithmic, or cloud connected and meets the highest standards of safety, reliability, and regulatory compliance.
The Principal Software Test Engineer functions as a technical authority in software verification, guiding cross functional teams in risk-based testing approaches and advanced test automation. This role influences technical direction without direct authority, partnering closely with Software Engineering, Systems Engineering, Quality, and Regulatory to ensure robust and compliant product development.

Key Responsibilities
Testing Strategy & Leadership
• Lead the development and execution of the overall software testing strategy for medical device products, ensuring alignment with system requirements, risk controls, and regulatory expectations.
• Drive risk based verification activities to ensure high risk features and failure modes receive appropriate coverage and depth.
• Own and maintain the verification architecture across software, hardware, and integrated system components.

Test Frameworks & Automation
• Architect, build, and scale advanced test automation frameworks to support continuous integration and continuous validation activities.
• Develop automated test solutions for unit, integration, regression, interface, and system level testing.
• Evaluate and introduce new test tools, technologies, and methods to increase efficiency, coverage, and product quality.

Technical Execution
• Design and execute verification plans, protocols, and test cases—including both manual and automated approaches.
• Review test plans, automation scripts, and documentation created by other engineers to ensure consistency, completeness, and technical accuracy.
• Lead root cause investigations, defect triage meetings, and resolution activities for software and system level issues.

Cross Functional Collaboration
• Work across engineering, quality, regulatory, and program teams to ensure verification deliverables are aligned with product goals, schedules, and compliance needs.
• Serve as a technical mentor to test engineers, providing coaching on test design, automation, documentation practices, and risk based reasoning.
• Communicate verification status, risks, and readiness with clarity to both technical and non technical stakeholders.

Compliance & Documentation
• Ensure all verification activities meet medical device software regulations and standards, including (but not limited to):
o FDA 21 CFR Part 820
o IEC 62304
o ISO 14971
o IEC 60601 1 and related standards
• Produce and maintain high quality verification documentation that supports design history files, audits, and regulatory submissions.

Required Qualifications
• Bachelor’s or Master’s degree in Software Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or related technical field.
• 10+ years of experience in software testing, verification, or validation for embedded, application level, or medical device software.
• Expertise in developing test strategies, frameworks, and automation solutions for complex, multi component systems.
• Strong programming/scripting skills (e.g., Python, C/C++, Java, C#, or similar).
• Deep understanding of software architecture, embedded systems, real time operating systems, and hardware/software interactions.
• Demonstrated experience working within regulated environments (medical device preferred).
• Proven ability to mentor engineers and influence cross functional teams without direct authority.

Preferred Qualifications
• Experience with CI/CD pipelines and test automation within Jenkins, GitLab, or equivalent environments.
• Hands on experience testing hardware integrated systems, firmware, sensors, or signal processing algorithms.
• Familiarity with cybersecurity testing, reliability testing, or networked medical device systems.
• Advanced experience authoring verification protocols, traceability matrices, and regulatory documentation.

Soft Skills & Leadership Attributes
• Strong analytical and problem solving abilities.
• Clear communicator capable of breaking down complex technical topics for diverse audiences.
• Highly organized, documentation driven, and detail oriented.
• Collaborative mindset with demonstrated ability to lead through influence.
• Passionate about safety, reliability, quality, and excellence in medical device engineering.

About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.