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Medical Device Software Testing Jobs in California

NYTP

Sr. Manual Tester

San Diego, CA

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 ...

Cesna Recruitment

Senior Software Engineer

San Diego, CA · 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 ...

Apply Early

Cesna Recruitment

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 ...

Heartflow

Test Engineer III

San Francisco, CA

$130K - $160K/yr

Experience testing Software as a Medical Device (SaMD) or other regulated medical device software. * Working familiarity with medical device QMS practices and applicable standards (e.g., ISO 13485 ...

AstrixTechnology LLC

Be Seen First

Medical Device Assembler

Santa Rosa, CA · On-site

$20 - $25/hr

... and testing fixtures. * Perform in-process quality inspections and provide timely feedback ... Medical device, Petrochemical and Clinical Research.

Astrix Inc

Medical Device Assembler

Santa Rosa, CA · On-site

$22 - $24/hr

Pay: $22-24/hour Position Summary The Medical Device Assembly Technician is responsible for ... and testing fixtures. * Perform in-process quality inspections and provide timely feedback ...

Tempus

Senior Quality Engineer

Redwood City, CA · On-site +1

Lead risk assessments to determine testing strategies. * Be involved in the medical device software design controls activities, in accordance with the FDA Quality System Regulation, ISO 13485, GAMP5 ...

Lancesoft

Software Validation Engineer

Sylmar, CA · On-site

$40 - $46.66/hr

Medical device software validation experience Proven background testing and validating software in a regulated environment (FDA/ISO), including preparing validation documents and supporting audits.

Heartflow

Test Engineer III

San Francisco, CA · On-site

Experience testing Software as a Medical Device (SaMD) or other regulated medical device software. * Working familiarity with medical device QMS practices and applicable standards (e.g., ISO 13485 ...

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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 30, 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.

Is software testing a good career?

Medical device software testing is a specialized field that involves verifying the safety and functionality of software used in medical devices. It requires knowledge of testing tools, regulatory standards, and often involves certifications like ISTQB. The role offers steady demand due to strict industry regulations and the need for quality assurance in healthcare technology.

Will AI replace medical device sales jobs?

AI is unlikely to fully replace medical device sales jobs, as these roles require relationship-building, product knowledge, and negotiation skills that are difficult for AI to replicate. Instead, AI can support sales professionals by providing data analysis, customer insights, and automating routine tasks. Success in this field often depends on interpersonal skills, technical understanding, and certifications, which remain essential despite technological advancements.

What is the highest paying tech in the medical field?

In the medical device software testing field, roles such as senior software engineers, quality assurance managers, and regulatory compliance specialists tend to have the highest salaries. These positions often require advanced technical skills, certifications, and experience with medical standards like ISO 13485 or IEC 62304.

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 a QA in medical devices?

A QA (Quality Assurance) in medical devices involves systematically reviewing and testing software to ensure it meets safety, performance, and regulatory standards. QA professionals in this field often use validation, verification, and risk management processes, and may require knowledge of standards like ISO 13485 and FDA regulations.

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 June 2026, with employment types broken down into 3% As Needed, 84% Full Time, 10% Part Time, 1% Temporary, and 2% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $89,305 per year, or $42.9 per hour.

Sr. Manual Tester

NYTP

San Diego, CA

Contractor

Posted 10 days ago

Job description

Position: Sr. Consultant with experience in Medical Device validation and 62304 governance standards

Location: 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, implement and maintain test plans, protocols, test scripts and traceability matrix for design verification & validation

Execute protocols/test scripts and document results

Generate and/or update summary reports

Participate in process improvements

Ensure compliance with FDA device regulatory requirements, including DHF and 510(k)