Software QA Engineer – Medical Devices

Genalyte, Inc; San Diego (CA); On-site; USD 48,000 - 62,000; Full time

Benefits offered by this job

Equity participation

Annual bonus

Benefits package

Time off policy

Job summary

Genalyte, Inc. in San Diego, CA is seeking a Software Test Engineer I/II to develop and execute test plans, identify defects, and ensure software quality before release for both instrument and cloud platform components.

You will collaborate with developers, product managers, and QA to verify functionality, performance, and regulatory compliance, while mentoring junior test engineers and supporting FDA/ISO 13485 quality system practices.

Qualifications

• BS or MS in Computer Science or Engineering, or equivalent hands-on experience.
• 2+ years in software QA testing in regulated environments.
• Experience with Jira and test management software.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication; able to explain issues to non-technical stakeholders.
• Experience with automated testing tools is a plus (e.g., Selenium, Cypress).
• Familiarity with FDA/ISO 13485 quality systems is preferred.

Responsibilities

• Execute manual test cases and document results clearly.
• Log and track defects using issue-tracking tools.
• Perform regression, functional, and exploratory testing.
• Develop and maintain test cases, scripts, and reports.
• Collaborate with developers to reproduce issues.
• Support regulatory submissions with documentation.
• Mentor junior QA engineers.
• Contribute to QA process improvements.

Skills

Bug tracking

Analytical thinking

Communication

Regulatory awareness

Education

BS/MS in CS/Engineering

Tools

Jira

Test management

Job description

Genalyte, Inc. in San Diego, CA is seeking a Software Test Engineer I/II to develop and execute test plans, identify defects, and ensure software quality before release for both instrument and cloud platform components.

You will collaborate with developers, product managers, and QA to verify functionality, performance, and regulatory compliance, while mentoring junior test engineers and supporting FDA/ISO 13485 quality system practices.