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India HUB Chief Engineer - Marketed Port 

POSITION PURPOSE:

The India HUB Chief Engineer – Marketed Portfolio will provide end-to-end technical leadership for marketed Radiology software products within the Software India HUB. This role is accountable for ensuring product changes, enhancements, verification activities, and post-market support are delivered with strong technical rigor, quality, regulatory compliance, and lifecycle discipline.

The ideal candidate is a seasoned technical leader with deep experience in software-enabled regulated products, requirements and architecture ownership, verification and validation, risk management, and cross-functional stakeholder alignment. This role requires the ability to drive decisions, resolve technical ambiguity, and ensure sustained product performance while advancing Bayer’s mission and values.

YOUR TASKS AND RESPONSIBILITIES:

• Lead technical ownership of marketed software products across the full lifecycle, including requirements, architecture, design, verification, release, and post-market support.
• Own and maintain the Integrated Technical Development Plan, ensuring alignment of technical scope, risks, quality activities, and deliverables across teams.
• Translate business, user, regulatory, and quality needs into product and system requirements, including software and embedded requirements where applicable.
• Lead development and maintenance of Product Design Requirements, System Requirements Specifications, detailed software requirements, and related technical documentation.
• Drive software and embedded architecture, design, development, integration, and verification activities to completion
• Ensure design controls, traceability, risk management, and validation activities are embedded throughout the software lifecycle.
• Oversee verification and validation planning and execution, including test strategy, protocols, traceability, evidence generation, and defect resolution.
• Partner with Product Management, Quality, Regulatory, Cybersecurity, DevOps, and Engineering teams to support compliant delivery and controlled release of product changes.
• Lead technical assessment and implementation of product changes, enhancements, and corrective actions for marketed products.
• Provide technical support for post-market issues, including complaint assessment, investigation, design changes, and knowledge transfer for long-term product support.

WHO YOU ARE:

• Bachelor’s or master’s degree in computer science, software engineering, biomedical engineering, systems engineering, or a related technical field.
• 12+ years of experience in software engineering, systems engineering, product development, or technical leadership, preferably within medical device, healthcare, or other regulated domains.
• Demonstrated ability to lead cross-functional technical decision-making across Product Management, Quality, Regulatory, Cybersecurity, DevOps, and Engineering stakeholders.
• Proven experience in technical leadership for software, embedded, or software-enabled products.
• Strong background in software architecture, requirements engineering, design, verification, and lifecycle documentation.
• Experience working in regulated environments with design controls, validation, risk management, and traceability requirements.
• Strong understanding of design controls, software development lifecycle practices, verification and validation, risk management, traceability, and post-market change control.
• Ability to work flexible hours to accommodate collaboration with teams in different time zones.
• Proven experience sustaining products, including technical assessment of enhancements, defects, corrective actions, product investigations, and release readiness.
• Strong technical planning and execution skills, with the ability to manage priorities, dependencies, risks, and deliverables across distributed teams.
• Ability to handle confidential product, quality, regulatory, and technical information with discretion while applying sound engineering judgment to complex challenges.
• Skilled in influencing technical and business stakeholders, aligning priorities, and driving decisions in ambiguous or high-impact situations.

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

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