Lead Software Test Engineer

About Us

We are a MedTech startup based in Orange County, CA that is pioneering a novel approach for the treatment of heart failure.

Position Description

The Software Test Leader will be a critical contributor to the quality and reliability of the

system's digital ecosystem. This role will own verification and validation activities across our

embedded firmware and mobile applications, ensuring every layer of the product—from the

implant’s firmware to the patient-facing mobile app—meets the highest standards of safety and

performance.

This position will be responsible for designing and building scalable test automation frameworks,

executing rigorous test strategies, and partnering with firmware, software, and regulatory teams to maintain compliance throughout the product lifecycle. We are looking for an engineer who brings both depth in test engineering and a passion for building systems that protect patients.

Primary Responsibilities

• Test Automation: Design, develop, and maintain automated test frameworks using Python and PyTest for embedded firmware verification and regression testing.
• Mobile App Testing: Build and extend mobile application test automation for Android and iOS using Appium and the Page Object Model (POM) pattern.
• Embedded Firmware Verification: Execute functional, integration, regression, performance, and end-to-end testing of embedded firmware for the implant.
• System Integration Testing: Validate end-to-end data flow from implant firmware through BLE communication to the mobile app and cloud platform.
• CI/CD Integration: Support the integration of automated tests into CI/CD pipelines to improve deployment speed, traceability, and regression coverage.
• Test Equipment Operation: Operate and automate test equipment including oscilloscopes, digital multimeters, and National Instruments tools.
• Defect Management: Troubleshoot and debug firmware and software defects; document findings in JIRA and collaborate with development teams on resolution.
• Regulatory Compliance: Ensure testing activities comply with FDA QSR, ISO 13485, ISO 14971, and IEC 62304 standards throughout the development lifecycle.
• V&V Documentation: Prepare and review verification and validation documentation including test plans, test reports, and requirements traceability matrices.
• Risk Management: Contribute to FMEA and risk management activities to identify potential failure modes and ensure mitigation through robust verification strategies.
• Regulatory Submissions: Support 510(k) and PMA submissions by providing verification and validation evidence and traceability documentation.

Experience and Skills Required

• Degreed in Engineering
• Demonstrated relevant experience in developing and scaling automated test frameworks
• Experience working with medical devices or other highly regulated industries
• Experience working in a startup or early-stage company environment is preferred
• HIL testing experience with systems driven by bluetooth