Job Description

Job Description

Note- Need to have device testing experience in Medical Device Domain

Key Responsibilities:

• 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.

Required Qualifications:

• Bachelor’s or Master’s 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.

Preferred Qualifications:

• Knowledge of ISO 14971, ISO 13485, and other relevant standards.
• PMP or similar certification is a plus.

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