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Medical Device Software Testing Jobs in California

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 ...

New

Abbott

Software Compliance Engineer

Milpitas, 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

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

Milpitas, 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 ...

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 ...

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 ...

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All JobsMedical Device Software Testing JobsMedical Device Software Testing Jobs in California

Medical Device Software Testing information

See California salary details

$18

$42

$69

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

As of Jul 22, 2026, the average hourly pay for medical device software testing in California is $42.94, according to ZipRecruiter salary data. Most workers in this role earn between $32.98 and $51.73 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.
What are popular job titles related to Medical Device Software Testing jobs in California? For Medical Device Software Testing jobs in California, the most frequently searched job titles are:
What job categories do people searching Medical Device Software Testing jobs in California look for? The top searched job categories for Medical Device Software Testing jobs in California are:
Medical Device Software Testing jobs near you
Infographic showing various Medical Device Software Testing job openings in California as of July 2026, with employment types broken down into 78% Full Time, 14% Part Time, and 8% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $89,305 per year, or $42.9 per hour.
Software Quality Engineer

Software Quality Engineer

Abbott

Alameda, CA • On-site

$80 - $85/hr

Contractor

Medical, Dental, Vision, Life, Retirement

Posted 12 days ago

Job description

Title: Software Quality Engineer
Location: Alameda, CA
Duration: 12 Month Assignment
100% Onsite
Summary: Participates as a member of the Software Quality Assurance (SWQA) team for Abbott Diabetes Care products that ensures digital applications produced by ADC is developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements.
Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software.
Coordinate activities with other engineering disciplines, departments, and contractors.
Duties:
  • 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 deliverables/activities as identified in the ADC Design Control Process/project plan or equivalent project plan. Including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports for the Alameda site.
  • Ensures unexpected events, issues or software bugs which occur during verification/validation are addressed and/or processed under relevant design control and defect management procedures.
  • Ensures compliance to relevant FDA QSR, ISO guidelines (ISO 13485, ISO 14971), including 21 CFR Part 11 and Abbott Diabetes Care requirements as they relate to the development, verification, validation, and maintenance of medical device software.

Qualifications:
  • Bachelor's degree, or equivalent experience, in a scientific, technical, or engineering discipline.
  • 2 to 5 years' experience in Software Quality Assurance and/or Software Testing experience.
  • Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of Design Control requirements.
  • Must have 1 - 3 years project experience in software quality assurance practices, methodologies including Agile and techniques, preferably in medical device software such as web and mobile applications.
  • Must have excellent oral and written communication skills.
  • ASQ Certifications a plus.
  • Medical Device experience strongly preferred.
  • Cybersecurity, medical web and mobile applications or AI experience preferred.

Consultants Eligible Benefits Upon Waiting Period:
  • Medical and Prescription Drug Plans
  • Dental Plan
  • Vision Plan
  • Health Savings Account (for High Deductible Health Plans)
  • Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
  • Supplemental Life Insurance
  • Short Term Disability (coverage varies by state)
  • Long Term Disability
  • Critical Illness, Hospital coverage, Accident Insurance
  • MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
  • 401(k)

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, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.
  • Published on 10 Jul 2026, 11:03 PM

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