4 days ago
Hyderābād, IndiaStaff+
Responsibilities
- Own end-to-end software verification for cloud services, mobile applications, and connected devices.
- Translate product and technical requirements into verification strategies, test plans, test cases, and execution plans.
- Develop and maintain verification plans, protocols, and reports compliant with FDA 21 CFR, ISO 13485, IEC 62304, and related standards.
- Partner with product managers, architects, developers, and quality teams on testability, traceability, and verification alignment.
- Support risk analysis, defect triage, impact assessments, and root-cause investigations.
- Participate in design reviews and verify that design inputs and outputs meet regulatory and quality expectations.
- Design and implement scalable manual and automated functional, integration, system, and regression testing strategies.
- Improve verification processes, tools, metrics, and automation coverage.
- Mentor junior test engineers in engineering discipline, automation practices, and regulatory excellence.
Requirements
- Bachelor’s degree in software engineering or a related field, or equivalent practical experience.
- 10+ years of experience in software verification and quality engineering.
- 3+ years of experience in medical-device software development under FDA 21 CFR 820, ISO 13485, and IEC 62304.
- Strong expertise in medical-device verification and validation, defect management, and requirements traceability.
- Experience identifying and implementing test-automation opportunities across mobile, web, API, or similar platforms.
- Hands-on experience building scalable automation frameworks using tools such as PyTest, Playwright, Jest, or REST Assured.
- Proficiency in Python, JavaScript, or TypeScript, with the ability to create reusable automation tools.
- Excellent analytical, communication, and documentation skills.
- Preferred: healthcare or regulated-industry experience; knowledge of SDLC, QA methodologies, HIPAA, and GDPR; software-and-hardware integration and end-to-end testing experience; and familiarity with cloud-native architectures and microservices testing.
Benefits
- Career development opportunities with an international company.
- Potential qualification for free medical coverage through Abbott’s Health Investment Plan PPO in the next calendar year.
- Retirement savings plan with a high employer contribution.
- Tuition reimbursement, the Freedom 2 Save student debt program, and the FreeU education benefit.
- Role location: Hyderabad, India.
Tech Stack
Categories
About Abbott
Abbott is a NYSE‑listed healthcare company that develops diagnostics, medical devices, nutrition products, and branded generic medicines for clinicians and consumers. Founded in 1888 and headquartered in Abbott Park, Illinois, it sells products in more than 160 countries, including the FreeStyle Libre continuous glucose monitoring system. Revenue comes primarily from product sales to hospitals, clinics, and retail channels.