At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

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 Bayer's 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:

• Bachelor’s or Master’s 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

Ever feel burnt out by bureaucracy? Us too. That's why we're changing the way we work- for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here

https://www.bayer.com/enfstrategyfstrategy

Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext.

Please don’t rely upon any unsolicited email from email addresses not ending with domain name “bayer.com” or job advertisements referring you to an email address that does not end with “bayer.com”. For checking the authenticity of such emails or advertisement you may approach us at HROP_INDIA@BAYER.COM.