Software V&V, Director

Key Responsibilities:

• Develop and execute V&V strategy for complex medical ecosystems involving hardware, firmware, software, and cloud components.
• Lead and mentor a high-performing team of test engineers, automation specialists, and quality analysts.
• Foster a culture of accountability, innovation, and continuous improvement within the V&V organization.
• Collaborate with cross-functional teams including product management, systems engineering, and regulatory affairs.
• Oversee system-level, integration, and end-to-end testing across platforms.
• Ensure compliance with FDA, ISO 13485, IEC 62304, and other relevant standards.
• Drive adoption of test automation tools and CI/CD pipelines.
• Lead risk-based testing approaches and ensure traceability of requirements to test cases.
• Represent V&V in design reviews, risk assessments, and audits.
• Communicate effectively with senior leadership, stakeholders, and external partners.

• Bachelor s or Master s degree in Computer Science, Biomedical Engineering, or related field.
• 10+ years of experience in software testing, with 5+ years in leadership roles.
• Proven experience in medical device software V&V, including embedded systems and cloud-connected platforms.
• Strong understanding of regulatory standards (FDA, ISO 14971, IEC 60601, IEC 62304).
• Demonstrated leadership skills including team building, strategic planning, and cross-functional collaboration.
• Experience with test automation frameworks and tools.
• Excellent communication, decision-making, and stakeholder management skills.

Preferred Qualifications:

• Experience with tools such as TestRail, Selenium, Jenkins, Azure DevOps.
• Familiarity with cybersecurity testing and interoperability standards (e.g., HL7, DICOM).
• Knowledge of Agile, DevOps, and risk-based testing methodologies.
• Experience with web-based and cloud-based medical applications.

Job Profile Attributes:

• Job Level: Director
• Job Function: Engineering / Quality
• Employee Type: Regular
• Work Schedule: Full-Time
• Location: Bengaluru, India
• Travel Required: Yes - up to 20%
• Reports To: Sr. Director, Software Engineering