More jobs:
Software Test Engineer
Job in
Los Angeles, Los Angeles County, California, 90079, USA
Listed on 2026-05-18
Listing for:
ANEUVO
Full Time
position Listed on 2026-05-18
Job specializations:
-
Software Development
Software Testing
Job Description & How to Apply Below
Role Overview
The Software Test Engineer – Sustaining Products is responsible for verification and validation activities supporting commercialized and post‑market software. This role focuses on testing software changes, defect fixes, cybersecurity updates, and maintenance releases while ensuring compliance with medical device regulations and quality system requirements. This role works closely with Software Engineering, Quality, Regulatory, and Product teams in a fast‑paced startup environment.
Key Responsibilities- Sustaining software Testing
- Plan and execute software verification and regression testing for sustaining releases
- Support testing of bug fixes, enhancements, cybersecurity updates, and infrastructure changes
- Develop and maintain test protocols, test cases, and traceability for post‑market software changes
- Execute impact‑based testing aligned with change risk and regulatory requirements
- Verification, Validation & Documentation
- Author, review, and maintain software test plans, protocols, and reports
- Ensure test evidence supports design change documentation and regulatory submissions
- Maintain traceability between software requirements, risks, and test cases
- Support updates to DHF, software lifecycle documentation, and Technical Documentation
- Automation & Tools
- Develop and maintain automated test scripts where appropriate to support regression testing
- Utilize defect tracking and test management tools to document issues and results
- Support continuous improvement of test processes and tooling in a startup environment
- Identify, document, and track software defects through resolution
- Collaborate with Software Engineering on root cause analysis and corrective actions
- Support Quality and Regulatory teams during investigations, CAPAs, and field issue assessments
- Compliance & Audit Support
- Ensure testing activities comply with IEC 62304, ISO 13485, 21 CFR 820, and applicable FDA guidance
- Support internal and external audits, inspections, and regulatory inquiries
- Contribute to risk management activities per ISO 14971
- Bachelor’s degree in computer science, Software Engineering, Biomedical Engineering, or related field
- 5+ years of software test experience, preferably in medical devices or regulated industries
- Experience with manual and automated software testing
- Familiarity with software lifecycle standards (IEC 62304 preferred)
- Experience supporting commercial or post‑market software
- Experience in a medical device startup or small company
- Experience testing SaMD, cloud‑based, or software‑enabled devices
- Familiarity with cybersecurity testing and vulnerability remediation
- Experience with test automation frameworks (e.g., Python, Selenium, pytest, CI/CD tools)
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