Position Summary

The Software Test Engineer I/II is responsible for developing and executing test plans, identifying defects, and helping ensure software products meet quality standards before release. This role works closely with developers, product managers, and QA team members to verify functionality, usability, performance, and reliability. The ideal candidate is detail-oriented, organized, and eager to learn software testing best practices in a fast-paced environment. The Software Test Engineer I/II will also help ensure compliance with regulatory requirements, maintain quality system processes, and support the development of IVD products. Genalyte’s product includes both a physical instrument and a cloud-hosted platform and testing activities will span across those two elements.

Essential Functions & Responsibilities

These may include but are not limited to:

• Execute manual test cases, collect evidence, and document test results clearly and accurately
• Identify, log, and track software defects using issue-tracking tools (e.g., Jira)
• Perform regression tests to verify bug fixes and updated features
• Develop and maintain test cases, test scripts, and test report documentation
• Collaborate with developers to reproduce issues and clarify expected behavior
• Participate in sprint planning, reviews, and daily stand-ups
• Perform functional, regression, smoke, and exploratory testing
• Help ensure software meets user requirements and acceptance criteria
• Support regulatory submissions with documentation and evidence generation
• Mentor more junior test engineers
• Contribute to continuous improvement of QA processes: Review requirements, specifications, and technical design documents to provide timely and meaningful feedback to test developers
• 
  
• 
  

Education, Experience, Knowledge, Skills & Abilities

• Prior experience in medical devices, diagnostics (IVD), or healthcare technology in a regulated environment required
• Education: BS/MS degree in Computer Science, Engineering, or a related subject (or equivalent hands-on experience)
• Technical Proficiency: Familiarity with bug tracking tools (e.g., Jira) and test management software
• Analytical Mindset: Ability to think through complex "edge cases" where a system might fail
• Communication: Excellent written and verbal communication skills; you must be able to explain technical flaws to non-technical stakeholders
• Experience: 2+ years of experience in software quality assurance testing or a related field
• Preferred Qualifications:
  • Experience with automated testing tools like Selenium, Cypress, Postman, or Playwright
  • Exposure to Agile/Scrum development environments
  • Knowledge of SQL, APIs, or web technologies (HTML, CSS, JavaScript) (Python, JavaScript, Postman)
  • Confident in testing on both cloud-hosted platforms and physical instruments
• Preferred Skills & Competencies
  • Problem-solving mindset
  • Strong written and verbal communication
  • Organization and time management
  • Curiosity and willingness to learn
  • Ability to follow test procedures precisely
  • Understanding of software validation concepts
  • Experience working under FDA, ISO 13485, or similar quality systems
• Familiarity with documentation requirements and traceability
  •