Sr Manager - SW Engineering

Overview

Lead a software engineering organization responsible for the development and lifecycle management of regulated software used in a high-acuity care environment, including the responsible adoption of AI-augmented engineering practices.

What you'll do

• Own software development execution within the team's area of responsibility.
• Lead design, development, verification, maintenance, and release activities for regulated software products.
• Drive adoption of modern software engineering practices, including CI/CD, DevOps, test automation, observability, and engineering productivity improvements within the constraints of regulated development environments.
• Establish and monitor engineering metrics related to quality, predictability, productivity, technical debt, and delivery performance.
• Partner with architecture, systems engineering, and product leadership to define technical direction and execution strategy.
• Lead the responsible adoption of AI-enabled engineering practices across software development, testing, documentation, planning, and analysis.
• Identify high-value opportunities where AI can improve engineering productivity, quality, consistency, and decision-making.
• Establish repeatable AI-enabled workflows, templates, prompt libraries, and engineering practices that can be reused across teams.
• Ensure AI-generated outputs are appropriately reviewed, validated, and governed before use in regulated product development activities.
• Promote effective use of approved AI tools while maintaining compliance with company policies, security requirements, intellectual property protections, and regulatory expectations.
• Track and communicate measurable improvements resulting from AI adoption, including cycle time, quality, automation, and engineering efficiency.
• Lead, develop, and inspire a high-performing software engineering team, promoting psychological safety, diversity, and inclusion.
• Provide coaching, mentoring, career development, and performance management.
• Partner with HR and leadership on hiring, workforce planning, succession planning, and organizational development.
• Coach team members and engineering leaders in the effective and responsible use of AI.
• Ensure compliance with applicable medical device software regulations and standards, including IEC 62304, ISO 13485, MDR, and applicable FDA expectations.
• Partner with Quality and Regulatory teams to support audits, inspections, and submissions.
• Ensure software lifecycle documentation, including requirements, design, verification, validation, risk management, and traceability, is complete, accurate, and audit-ready.
• Champion a quality-by-design mindset across software teams.
• Ensure AI-enabled practices comply with applicable data privacy, cybersecurity, intellectual property, quality, and regulatory requirements.
• Work with Program Management to define scope, milestones, risks, and dependencies.
• Collaborate with Product Management and Systems Engineering to align technical execution with customer and business needs.
• Communicate progress, risks, trade-offs, and recommendations clearly to senior leadership and stakeholders.
• Support post-market activities, including incident investigation, root cause analysis, corrective actions, and continuous product improvement.

What you'll need

• Bachelor's degree in an applicable technical or clinical field, such as Computer Science, Software Engineering, Engineering, or Clinical Informatics.
• Minimum 15+ years of experience in the related field.
• Demonstrated experience delivering regulated software, preferably for medical devices or other safety-critical systems.
• Strong understanding of software development lifecycles, including Agile, hybrid, or V-model approaches in regulated environments.
• Demonstrated experience leading teams through complex, multi-release products.
• Excellent communication and influencing skills across functions and leadership levels.
• Demonstrated applied experience using AI in software engineering or product-development workflows and driving responsible adoption within a team.
• Experience validating and governing AI-generated outputs for quality, security, privacy, and compliance.
• Ability to balance innovation, productivity, quality, patient safety, regulatory compliance, cybersecurity, and business objectives.

Nice to have

• Experience with IEC 62304 software lifecycle processes and FDA/MDR regulatory expectations.
• Familiarity with DevOps, CI/CD, and automated verification in regulated environments.
• Previous participation in regulatory audits, inspections, or submissions.
• Experience establishing reusable AI-enabled engineering practices and measuring their impact on productivity, quality, or delivery performance.
• Knowledge of responsible AI practices, AI governance, cybersecurity, privacy, and compliance considerations.
• Experience coaching teams and leaders in responsible AI adoption.

Details

• Location: Bengaluru, India (IND19-01, EPIP 122 Phase II).
• Relocation assistance: not provided.