Software Validation Engineer

Insight Global; Irvine (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading company is seeking a V&V Software Testing Automation Engineer to support advanced neuromodulation technologies. The role involves developing automated test strategies for medical devices, ensuring regulatory compliance, and collaborating with various teams. A Bachelor's or Master's degree along with 3-7 years of experience in automated testing is required, alongside proficiency in languages such as Python and C/C++. Competitive compensation and a comprehensive benefits package are offered.

Benefits

Medical, dental, and vision insurance

401k retirement account with employer matching

Paid sick leave

Flexible spending accounts (HSA, FSA, DCFSA)

Qualifications

• 3-7 years of experience in automated testing in a regulated industry (medical device preferred).
• Proficiency in test automation tools and familiarity with embedded systems.
• Experience with FDA Class II/III devices and regulatory standards.

Responsibilities

• Design, develop, and maintain automated test frameworks for neuromodulation systems.
• Execute automated and manual tests, analyze results, and document findings.
• Collaborate with cross-functional teams to define test plans and ensure compliance.

Skills

Python

C/C++

Java

Automated Testing

Analytical Skills

Communication

Education

Bachelor’s or Master’s degree in Computer Science, Software Engineering, Biomedical Engineering

Tools

Robot Framework

TestComplete

Squish

CI/CD pipelines

Jenkins

Git

JIRA

Job description

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We are seeking a V&V Software Testing Automation Engineer to join a high-impact team supporting the integration of advanced neuromodulation technologies. This role focuses on developing and executing automated test strategies for implantable and external medical devices, ensuring compliance with regulatory standards and delivering safe, effective solutions to patients.

• Design, develop, and maintain automated test frameworks and scripts for embedded and application-level software used in neuromodulation systems.
• Collaborate with Systems, Software, and Quality teams to define test plans, test cases, and traceability to requirements.
• Execute automated and manual tests, analyze results, and document findings in accordance with FDA, ISO 13485, and IEC 62304 standards.
• Support regression testing, continuous integration (CI), and design verification activities. Contribute to risk-based testing strategies and ensure test coverage for safety-critical functions.
• Participate in code reviews, test reviews, and design reviews to ensure quality and compliance. Assist in the integration of legacy systems and tools from recent acquisitions into the existing V&V infrastructure.

Must-Haves:

• Bachelor’s or Master’s degree in Computer Science, Software Engineering, Biomedical Engineering, or related field.
• 3–7 years of experience in automated software testing within a regulated industry (medical device preferred).
• Proficiency in Python, C/C++, or Java, and experience with test automation tools such as Robot Framework, TestComplete, Squish, or similar.
• Familiarity with embedded systems, real-time operating systems (RTOS), and hardware-in-the-loop (HIL) testing.
• Experience with FDA Class II/III medical devices and standards like IEC 62304, ISO 14971, and ISO 13485.
• Strong understanding of CI/CD pipelines and tools like Jenkins, Git, and JIRA.
• Excellent analytical, documentation, and communication skills.

Compensation: $74/hr

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

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