Lead Systems Designer – IoMT Installed Base (IB)

Overview

Senior technical leader responsible for the architecture, reliability, compliance, and lifecycle evolution of deployed PCS IoMT products and platforms, acting as technical authority for the installed base portfolio.

What you'll do

• Lead system architecture, design, and technical strategy for the installed product portfolio, ensuring reliability, scalability, security, and regulatory compliance.
• Provide technical leadership across the product lifecycle, including product enhancements, sustaining engineering, modernization, obsolescence management, and technology refresh initiatives.
• Lead investigations of customer, field, quality, and cybersecurity issues, driving root cause analysis, impact assessments, corrective actions, and long-term solutions.
• Partner with Product Management, Engineering, Quality, Service, Regulatory, and Operations teams to translate customer and business needs into robust system solutions.
• Define and manage system requirements, architecture, subsystem boundaries, interfaces, and traceability throughout the product lifecycle.
• Drive architectural reviews, technology evaluations, design trade-off decisions, and implementation strategies across multiple product releases.
• Ensure compliance with QMS, Design Control, Risk Management, CAPA, Change Control, and applicable regulatory requirements.
• Mentor engineering teams on systems engineering best practices, requirements flow-down, risk analysis, verification and validation, and design integration.
• Drive adoption of modern engineering practices, including AI-assisted development, automation, and productivity tools to improve engineering effectiveness.
• Lead impact assessments for supplier changes, component obsolescence, manufacturing transfers, and product change initiatives.
• Own technical content and quality deliverables supporting design reviews, customer documentation, verification activities, and regulatory submissions.
• Collaborate with global stakeholders to deliver sustainable, fault-tolerant, and cost-effective solutions while managing technical risks and execution priorities.
• Act as a technical mentor and trusted advisor, helping teams navigate complex technical challenges, ambiguity, and competing priorities.

What you'll need

• Bachelor's or master's degree in computer science, Software Engineering, Systems Engineering, Biomedical Engineering, or other STEM disciplines.
• Overall 10+ years of industry experience in software, systems engineering, or product development.
• 3+ years of experience in MedTech or regulated product development environments.
• Strong expertise in Systems Engineering, System Architecture, QMS, Design Controls, Risk Management, and Product Lifecycle Management.
• Demonstrated experience leading customer and field issue investigations, CAPA activities, change management, and cross-functional technical initiatives.

Nice to have

• Expertise in CAPA, CCN, ECR/ECO, SCR, defect triage, field issue investigations, risk reviews, CMF/CMT, and design change processes.
• Experience with connected healthcare systems, cloud platforms, EMR interoperability, communication protocols, and software verification.
• Proven ability to influence across organizations and lead without direct authority.
• Excellent communication, stakeholder management, and technical mentoring skills.

Details

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