NPD Test Lead- Embedded systems, Mobile app Remote Location - Sierra Business Solution LLC

Burlington MA

Job Description:

>> Lead end-to-end NPI activities for embedded software testing in medical devices.

>> Oversee Test protocols, test strategy and test automation testing aligned with IEC 62304 standards.

>> Manage and troubleshoot communication protocols including BLE, Serial, SPI, UART.

>> Utilize protocol sniffers and debugging tools to resolve technical issues.

>> Ensure compliance with FDA guidelines, SaMD testing protocols, and other regulatory standards.

>> Collaborate with cross-functional teams across onsite and offshore locations to resolve technical challenges.

>> Drive Software Testing Life Cycle (STLC) processes and ensure quality assurance.

>> Interface with regulatory bodies and support documentation for audits and submissions.

>> Communicate effectively with stakeholders, including engineering, QA, regulatory, and product teams.

Requirements:

>> Bachelors or Masters degree in Computer Science, Electronics, Biomedical Engineering, or related field.

>> 12+ years of experience in embedded software testing for medical devices

>> Experience with Appium or any other mobile test automation framework

>> Strong understanding of IEC 62304, FDA regulations, and SaMD standards.

>> Knowledge with BLE, Serial, SPI, UART communication protocols.

>> Proficiency in using protocol sniffers and debugging tools.

>> Proven experience managing offshore and onsite teams.

>> Excellent communication, leadership, and problem-solving skills.

>> Familiarity with STLC, risk management, and design controls.

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