Lead Systems Designer - IoMT Installed Base (IB)

GE HealthCare; Karnataka; On-site; INR 4,000,000 - 6,500,000; Full time

Job summary

GE Healthcare is seeking a Lead Systems Designer to own the architecture and lifecycle evolution of PCS IoMT products. You will drive technical strategy, ensure regulatory compliance, and mentor engineers across multiple teams to deliver scalable, compliant solutions.

Role requires deep systems thinking, collaboration with product management, quality, and regulatory teams, and hands-on leadership in design reviews and risk management.

Qualifications

• 10+ years of experience in software, systems engineering, or product development.
• 3+ years in MedTech or regulated product development environments.
• Expertise in systems engineering, architecture, QMS, design controls, risk management and PLM.

Responsibilities

• Lead system architecture, design, and technical strategy for the installed product portfolio.
• Provide technical leadership across the product lifecycle including modernization and obsolescence management.
• Lead investigations of customer, field, quality, and cybersecurity issues with root cause analysis.
• Collaborate with cross-functional teams to translate customer and business needs into robust system solutions.
• Define and manage system requirements, architecture, interfaces, and traceability.
• Drive architectural reviews, technology evaluations, and design trade-offs across releases.
• Ensure compliance with QMS, Design Controls, Risk Management, CAPA, and regulatory requirements.
• Mentor engineering teams on systems engineering best practices and verification activities.

Skills

Systems Engineering

System Architecture

QMS

Design Controls

Risk Management

Product Lifecycle

CAPA

Leadership

Education

Bachelors or Masters in STEM

Job description

Job Description Summary

The Lead Systems Designer is a senior technical leader responsible for the architecture, reliability, compliance, and lifecycle evolution of deployed PCS IoMT products and platforms. This role provides system-level leadership across the installed base portfolio, driving technical strategy, architectural decisions, product enhancements, modernization initiatives, and complex customer issue investigations. Working closely with Engineering, Product Management, Quality, Service, Regulatory, Cybersecurity, and Operations teams, the Lead Systems Designer ensures solutions are scalable, compliant, maintainable, and aligned with business and customer needs. The role serves as a key technical authority in root cause investigations, risk assessments, design reviews, and change management activities, while ensuring adherence to Quality Management System (QMS) requirements and regulatory standards. Combining deep systems thinking with strong technical expertise, this leader drives continuous improvement, guides cross-functional teams through ambiguity, and delivers high-quality solutions that enhance product performance, customer satisfaction, and long-term business value.

Job Description

• 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.

Required Qualifications

• 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.

Desired Characteristics

• 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.

Inclusion and Diversity

GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into worl