- 经验
- 10–15 yrs
- 薪水
- —
- 职位空缺
- 1
- 发布
- 5小时前
- Work mode
- 在办公室
- 学历
- Bachelor’s degree in Computer Science, Electronics, Biomedical, or equivalent
- Eligibility
- Candidates with the stated degree and experience background in software testing/V&V, especially within regulated medical device environments and NPD programs, are suitable for this role.
- Resume
- Required to apply
Where you'll work
职位描述
About the Company
Tata Elxsi partners with prominent medical device OEMs and technology firms across market research, human factors engineering, hardware and software development, verification and validation, regulatory standards, compliance, artificial intelligence, cloud, and IoT. Its Medical Device and Healthcare division is certified to ISO 13485.
Role Overview
This position is for a Test Leader / Test Manager working on new product development in the medical device space. The role focuses on leading verification and validation activities from planning through execution while ensuring strong product quality and regulatory alignment.
Key Responsibilities
- Own the test strategy, planning, and execution for new product development programs.
- Build and maintain the V&V approach in line with IEC 62304, ISO 13485, and FDA expectations.
- Handle functional, system, integration, and regression testing across the program lifecycle.
- Develop and strengthen automation approaches using C++, Squish, and related frameworks.
- Oversee GUI validation for applications built on Qt/QML.
- Maintain traceability and test tracking in JIRA.
- Work closely with R&D, system engineering, and product teams to align on quality goals.
- Apply risk-based testing methods for safety-critical solutions.
- Monitor quality indicators, defect trends, and overall test progress.
- Support audits, design reviews, and documentation needed for regulatory submissions.
Required Skills and Knowledge
- Background in testing regulated products, especially medical devices.
- Practical experience with C++ testing and debugging.
- Strong capability in Qt/QML application testing and GUI validation.
- Hands-on exposure to Squish for GUI automation.
- Working knowledge of JIRA and ALM-style tracking tools.
- Clear understanding of SDLC and the V-model.
- Experience leading teams and managing test delivery.
- Familiarity with IEC 62304, ISO 13485, and FDA compliance requirements.
Preferred Experience
- Exposure to Agile or Scrum delivery methods.
- Experience testing embedded systems and HMI interfaces.
- Understanding of CI/CD pipelines and how automation fits into them.
- Awareness of ISO 14971 risk management practices.
Education
A bachelor’s degree in Computer Science, Electronics, Biomedical, or a closely related field is required.
Experience
The role calls for 10–15+ years of experience in software testing or verification and validation, including 3–5+ years in test leadership positions. Prior work on new product development programs is expected.