Medical Product Test Lead

Larsen & Toubro (L&T); Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Larsen & Toubro (L&T) invites an experienced Test Lead to oversee end-to-end testing for medical products. You will define test strategy, plans and quality processes, while guiding a team of test engineers to ensure robust product quality.

You will collaborate with Product, R&D, Regulatory and Clinical teams to ensure adherence to FDA, IEC 62304, ISO 13485 and ISO 14971, and to drive risk-based testing and continuous quality improvements.

Qualifications

• Lead the testing strategy, plans and quality processes for medical products.
• Champion risk-based testing and ensure RTM coverage across modules.
• Mentor test engineers and drive defect management and RCA.
• Collaborate with Product, R&D, Regulatory and Clinical teams to align quality goals.

Responsibilities

• Lead end-to-end testing activities for medical products.
• Define test strategy, test plans, and quality processes.
• Manage functional, integration, system, regression, and performance testing.
• Ensure compliance with FDA, IEC 62304, ISO 13485, and ISO 14971 standards.
• Perform risk-based testing and maintain RTM coverage.
• Drive defect management, RCA, and quality improvements.
• Lead and mentor test engineers.
• Collaborate with Product, R&D, Regulatory, and Clinical teams.

Skills

Test leadership

Risk-based testing

Quality assurance

Regulatory compliance

Tools

JIRA

ALM

Azure DevOps

Polarion

DOORS

HL7

DICOM

Job description

Role & responsibilities

• Lead end-to-end testing activities for medical products.
• Define test strategy, test plans, and quality processes.
• Manage functional, integration, system, regression, and performance testing.
• Ensure compliance with FDA, IEC 62304, ISO 13485, and ISO 14971 standards.
• Perform risk-based testing and maintain RTM coverage.
• Drive defect management, RCA, and quality improvements.
• Lead and mentor test engineers.
• Collaborate with Product, R&D, Regulatory, and Clinical teams.

Preferred candidate profile

• Patient Monitoring Systems
• Diagnostic Equipment
• Healthcare Applications
• HL7 & DICOM
• JIRA / ALM / Azure DevOps / Polarion / DOORS