India HUB Test Architect

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India HUB Test Architect

POSITION PURPOSE:

The Test Architect is responsible for defining governing and continuously improving the test architecture and verification strategy for regulated medical device software including Software in a Medical Device (SiMD) as well as Software as a Medical Device (SaMD). The role ensures that verification and validation activities are risk based traceable compliant with regulatory standards and aligned with system architecture and product lifecycle needs.

This position provides technical leadership and architectural direction for software verification and validation activities across medical device programs. The Test Architect ensures compliance with FDA design controls IEC 62304 ISO 13485 and ISO 14971 while enabling efficient scalable and automation enabled testing practices. The role partners with cross functional stakeholders to embed quality throughout the software development lifecycle.

The ideal candidate will be a proactive leader who can drive outcomes and align with Bayers mission and values.

YOUR TASKS AND RESPONSIBILITIES:

• Test Architecture & Strategy

• Define and own the end to end test architecture for medical device software including system integration regression performance cybersecurity and usability testing.
• Architect risk based verification strategies aligned with intended use software safety classification and risk management activities.
• Ensure full traceability from user needs and system/software requirements to test cases execution and results.
• Establish standardized test patterns reusable assets and architectural guidelines across programs.

• Verification & Validation (V&V)

• Provide architectural oversight for software verification and validation activities across new product development (NPD) and lifecycle engineering (LCE).
• Review and assist in approval of software verification plans test protocols and verification reports.
• Ensure verification evidence supports Design History File (DHF) and regulatory submission requirements.
• Guide teams on appropriate balance of manual exploratory and automated testing based on risk.

• Regulatory & Compliance

• Ensure compliance with applicable standards and regulations including:
• IEC 62304 Medical Device Software Lifecycle
• ISO 13485 Quality Management System
• ISO 14971 Risk Management
• FDA Design Controls and relevant guidance
• Support internal and external audits inspections and health authority interactions.
• Ensure appropriate tool qualification / validation and data integrity controls are in place.

• Automation & CI/CD in Regulated Environments

• Architect and govern test automation frameworks across UI API data and platform layers.
• Define strategies for integrating testing into CI/CD pipelines while maintaining regulatory compliance traceability and auditability.
• Promote design for testability through early engagement with software and system architects.

• Technical Leadership & Mentoring

• Serve as a technical authority for testing and verification architecture across multiple teams or products.
• Provide mentoring and guidance to V&V engineers test leads and SDETs.
• Review and approve test strategies and architectural decisions for complex or high risk initiatives.
• Drive continuous improvement and maturity of the Software Assurance / V&V Center of Excellence (CoE).

• Cross Functional Collaboration

• Collaborate closely with software architects systems engineering cybersecurity clinical usability DevOps and regulatory teams.
• Provide objective quality input into release readiness risk acceptance and go/no go decisions.
• Communicate technical and compliance topics effectively across global cross functional teams.

WHO YOU ARE:

• Bachelors or Masters degree in Computer Science Software Engineering Biomedical Engineering or related discipline.
• 10 years of experience in software verification & validation / testing or quality engineering covering both devices and software solutions.
• 5 years in senior technical or architectural roles within regulated medical device or healthcare software environments.
• Strong understanding of medical device software development lifecycles and regulatory expectations.
• Proven experience designing manual and automated test frameworks.
• Proficiency in one or more programming/scripting languages (e.g. Python Java C# JavaScript).
• Experience working with industry leading automation tools and solutions (e.g. Tosca Squish Selenium Playwright etc.)
• Experience working with test repositories and ALM solutions (e.g. IBM-ETM/ERM JAMA etc.)
• Experience working in cross functional globally distributed R&D teams.

• Preferred -

• Experience with SaMD AI/ML based medical software or connected medical devices.
• Knowledge of cybersecurity performance reliability and interoperability testing for medical devices.
• Experience supporting Testing related to FDA submissions CE marking or global regulatory audits.
• Familiarity with cloud based medical device platforms and validated DevOps pipelines.

• Behavioral Competencies -

• Strong systems thinking and architectural mindset
• Risk based decision making
• Clear and effective communication with technical and regulatory stakeholders
• Mentoring and technical leadership
• Continuous improvement and quality mindset

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