Staff Software Test Engineer - Medical Device / Healthcare Technology

Title: Staff Software Test Engineer - Medical Device / Healthcare Technology

Location: Hyderabad

Job Overview

We are looking for an experienced Software Test Engineering professional to drive quality assurance and software validation for technology-driven healthcare products. The role involves working across cloud-based applications, mobile platforms and connected devices, with a strong focus on automation, product reliability and regulatory compliance.

Key Responsibilities

• Lead software quality and validation activities across web, mobile, cloud and connected-device applications.
• Review product specifications and technical requirements to define appropriate testing approaches and validation coverage.
• Prepare and maintain test strategies, test protocols, execution records and quality documentation.
• Ensure software verification activities follow applicable medical-device regulatory and quality standards.
• Develop and enhance automated testing solutions for functional, integration, system and regression testing.
• Work closely with software development, product engineering and quality teams to identify potential issues early in the development cycle.
• Monitor defects, conduct impact assessments and support root-cause investigations.
• Participate in technical reviews, risk assessments and product quality discussions.
• Improve testing efficiency through automation, process standardisation and appropriate quality metrics.
• Provide technical guidance and mentoring to junior engineers and testing team members.

Mandatory Skills, Qualification & Experience

• Bachelor's or Master's degree in Computer Science, Information Technology, Software Engineering or a related discipline.
• 10+ years of experience in Software Testing, Quality Engineering or Software Verification & Validation.
• Minimum 3 years of experience working in the Medical Device industry or regulated medical software environment.
• Strong understanding of medical device software lifecycle and verification processes.
• Practical knowledge of FDA 21 CFR, ISO 13485 and IEC 62304 standards.
• Experience in requirement traceability, risk-based testing, defect management and validation documentation.
• Hands-on experience developing or maintaining automation frameworks.
• Programming knowledge in Python, JavaScript or TypeScript.
• Exposure to automation tools/frameworks such as PyTest, Playwright, Jest or REST Assured.
• Experience in functional, integration, system and regression testing.
• Good communication, analytical and stakeholder-management skills.