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Medical Device Software Testing Jobs (NOW HIRING)

Natera

OR · On-site

$122K - $161K/yr

... device software, manage the cadence and prioritization of testing activities, and serve as the ... medical device software (510(k) and/or PMA pathways). * 3+ years designing and executing ...

Diality

Director, Software Engineering

Irvine, CA · Hybrid

$223K - $260K/yr

Description Company & Job Overview Diality is a medical device company focused on developing ... The Director of Software Engineering reports to Director of Product Development and leads Diality ...

Diality Inc

Director, Software Engineering

Irvine, CA · On-site

$223K - $260K/yr

Company & Job Overview Diality is a medical device company focused on developing solutions to ... The Director of Software Engineering reports to Director of Product Development and leads Diality ...

Aerotek

Medical Device Assembler

Irvine, CA

$19 - $23.25/hr

Clean Room Assembler / Medical Device Assembler This role focuses on assembling advanced medical ... Ability to adapt to new tools, software, and testing methods as products and processes evolve.

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Medical Device Software Testing information

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$19

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

As of Aug 12, 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?

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 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, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $90,490 per year, or $43.5 per hour.

Senior Software Quality Engineer - Design Controls

Abbott

Alameda, CA • On-site

Full-time

Medical, Life, Retirement

Re-posted 20 days ago

Abbott rating

7.8

Company rating: 7.8 out of 10

Based on 138 frontline employees who took The Breakroom Quiz

178th of 538 rated manufacturers

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
  • Career development with an international company where you can grow the career you dream of.
  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • An excellent retirement savings plan with a high employer contribution.
  • Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
  • A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity
This position works out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.
The Senior Software Quality Engineer - Design Controls will be responsible for (but not limited to) the following:
  • Participates as a lead member of the Software Quality Assurance (SWQA) team for Abbott Diabetes Care products to ensure medical device software is developed, tested and deployed in adherence to design control procedures.
  • Engages cross-functionally with R&D teams (systems engineering, project management, software development and test) to review and approve DHF deliverables.
  • Supports Agile teams as embedded design control SME throughout the product development and release cycle.
  • Drives compliance to defect management process to ensure investigations are timely and thorough, risks/hazards are assessed, and fixes are implemented.

What You'll Work On
  • Completes software quality tasks in accordance with current Quality System Requirements.
  • Works independently with objectives given by SWQA Manager.
  • Can plan and coordinate own work according to higher-level project schedules.
  • Reviews and provides lead guidance to the team regarding deliverables/activities as identified in project plans or equivalent documentation. Including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports for the Alameda site.
  • Reports unexpected events, issues or software bugs which occur during verification/validation to project team and management.
  • Coordinates the development and maintenance of departmental operating procedures to ensure compliance to relevant FDA, QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation, and maintenance of application in support of medical device software.
  • Software Quality lead in various phases of the development lifecycle, as well as initiation of corrective and/or preventative action as it applies software development activities.
  • Maintains schedule and drive to meet project schedule as aligned with project(s) goals.
  • Will also estimate, plan, schedule and review own and others' work products and be accountable for the quality of those reviews and delivery on schedule.
  • Considered SWQA compliance SME in support of external/internal audits.

Required Qualifications
  • Bachelor's degree, or equivalent experience, in a scientific, technical, or engineering discipline.
  • 2 to 5 years' experience in Software Design Quality Assurance and/or Software Testing experience.
  • Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of Design Control and Risk Management requirements.
  • Must have 1 - 3 years project experience in software testing practices, methodologies including Agile and techniques, preferably in testing medical devices and mobile applications.

Preferred Qualifications
  • Must have excellent oral and written communication skills.
  • ASQ Certifications a plus.
  • Medical Device experience strongly preferred.
  • Cybersecurity, medical mobile applications or cloud computing experience preferred.

Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.
The base pay for this position is
$90,000.00 - $180,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
ADC Diabetes Care
LOCATION:
United States > Alameda : 2901 Harbor Bay Parkway
ADDITIONAL LOCATIONS:
United States > Milpitas : 1820 McCarthy Blvd
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

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