Test Manager

Role #1 : Test Manager- Portals, Mobile app

Location : Chennai, Bangalore, Hyderabad

Individual to drive the Test strategy , test automation and introduction of software and mobile apps for cutting-edge medical devices. This role demands deep technical expertise in web portals, Mobile test automation, regulatory compliance, and cross-functional leadership to ensure successful product launches in a highly regulated environment.

Key Responsibilities:

• Lead end-to-end NPD/Sustenance activities for Portal and Mobile app 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.
• Define unified platform for Mobile and web applications for test automation
• Interface with regulatory bodies and support documentation for audits and submissions.
• Manage offshore and onsite team deliverables and guide them on techincal aspects
• Communicate effectively with stakeholders, including engineering, QA, regulatory, and product teams.

Required Qualifications:

• Bachelors or Master’s degree in Computer Science, Electronics, Biomedical Engineering, or related field
• Overall 14+ years of experience in Testing
• 10+ years of experience testing for medical devices for web application and mobile app or devices
• 3+ Experience with Appium or any other mobile test automation framework
• 5+ Experience with Selenium, Java
• Strong understanding of IEC 62304, FDA regulations, and SaMD standards.
• Hands-on experience 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:

• Experience with cybersecurity standards for medical devices.
• Knowledge of ISO 14971, ISO 13485, and other relevant standards.
• PMP or similar certification is plus.