MedTech Software Test Engineer – Sustaining & Compliance

ANEUVO; Los Angeles (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

Aneuvo is seeking a Software Test Engineer – Sustaining Products to verify and validate post-market software in a fast-paced startup. You will work with Software Engineering, Quality, Regulatory, and Product teams to test changes, fixes, cybersecurity updates, and maintenance releases while ensuring compliance with medical device regulations.

Responsibilities include planning and executing verification, maintaining test protocols, and documenting evidence for regulatory submissions.

Qualifications

• 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 test 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).

Responsibilities

• Sustaining software testing across releases.
• Plan and execute verification and regression testing.
• Support testing of bug fixes, cybersecurity updates, and infrastructure changes.
• Develop and maintain test protocols, test cases, and traceability.
• Execute impact-based testing aligned with change risk and regulatory requirements.
• Author, review, and maintain software test plans, protocols, and reports.
• Ensure test evidence supports design change documentation and regulatory submissions.
• Maintain traceability between requirements, risks, and test cases.
• Support DHF, software lifecycle documentation, and Technical Documentation.
• Develop and maintain automated test scripts for regression testing.
• Use defect tracking and test management tools to document issues and results.
• Collaborate with Engineering on root cause analysis and corrective actions.
• Support Quality and Regulatory teams during investigations, CAPAs, and audits.
• Ensure testing activities comply with IEC 62304, ISO 13485, 21 CFR 820, FDA guidance.

Skills

Software testing

Cybersecurity testing

Root cause analysis

Education

Bachelor's degree in Computer Science/Software Engineering/Biomedical Engineering

Tools

Python

Selenium

pytest

CI/CD

Job description

Aneuvo is seeking a Software Test Engineer – Sustaining Products to verify and validate post-market software in a fast-paced startup. You will work with Software Engineering, Quality, Regulatory, and Product teams to test changes, fixes, cybersecurity updates, and maintenance releases while ensuring compliance with medical device regulations.

Responsibilities include planning and executing verification, maintaining test protocols, and documenting evidence for regulatory submissions.