Test Manager
2 weeks ago
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.
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