Lead System Designer & Product Security Representative

I00M05 Wipro GE Healthcare Private Limited; Karnataka; On-site; INR 4,000,000 - 6,000,000; Full time

Job summary

GE HealthCare seeks a Lead System Designer / Product Security Representative to own QMS, SDL, and regulatory compliance for the Ethos Design System. Drive quality, security governance, and release integrity across component lifecycles to protect patient safety and ensure audit readiness.

You will partner with Product Management, UX, Engineering, Architecture, and Product Security to maintain documentation and accelerate compliant design and deployment while improving processes and automation.

Qualifications

• 10+ years of experience with Quality Management Systems (QMS) and regulated product development.
• Strong understanding of Secure Development Lifecycle practices.
• Experience coordinating security reviews, threat modeling, vulnerability management, and compliance activities.
• Familiarity with design controls, traceability, audit readiness, and release governance.
• Experience driving compliance automation and Agile processes.
• AI tooling experience to enhance workflows and documentation.

Responsibilities

• Own QMS-related activities across the EDS component lifecycle and DHF strategy.
• Develop, maintain, and govern design, development, verification, and release documentation with traceability.
• Coordinate audits, reviews, and signoffs ensuring regulatory compliance.
• Drive continuous improvement of quality processes and cTDR/dTDR/eTDR alignment.
• Serve as Product Security Representative and oversee SDL adherence.
• Coordinate security reviews, threat modeling, vulnerability management, and release validation.
• Partner with Engineering to implement secure coding and SBOM generation; track security metrics.

Skills

QMS ownership

Secure SDLC

Security governance

Risk management

Agile development

Leadership & cross-functional

Education

Bachelor's degree in Computer Science/Engineering

Tools

AI tools

Job description

Job Description Summary

We are seeking a Lead System Designer / Product Security Representative (LSD/PSR) to lead compliance, quality, and security governance for Ethos Design System (EDS) by ensuring all components meet QMS, regulatory, and secure development requirements throughout their lifecycle. This role ensures that components are designed, developed, verified, released, and maintained in accordance with Quality Management System (QMS) requirements, Secure Development Lifecycle (SDL) practices, regulatory expectations, and enterprise security standards. You will serve as the primary compliance steward for EDS, partnering with Product Management, UX, Engineering, Architecture, and Product Security teams to maintain audit readiness, security posture, documentation completeness, and release compliance. This includes complete ownership of QMS documentation, review coordination, approvals, and process compliance activities.

About the Ethos Design System (EDS)

EDS is the unified digital platform that powers GE HealthCare's global software portfolio. It serves as a comprehensive library of reusable UI components, design patterns, and accessibility standards that bridge the critical gap between User Experience (UX) and Engineering. By fostering a philosophy of "reduce, reuse, and recycle," EDS enables hundreds of product teams to eliminate redundant coding and design work. We provide the foundational building blocks that ensure our clinical and operational applications are intuitive, consistent, and accessible, allowing teams to focus on patient safety.

The Mission: Scale and Empowerment

We are in a phase of hyper-growth, scaling from 25 adopting products to over 100. This requires a leader who thinks like a founder. You must look beyond simple backlog management to think about scale, growth, and empowerment. You will build a self-service ecosystem that allows teams to move fast without breaking the consistent standards required for patient safety and accessibility.

Core Responsibilities

1. Quality & Compliance
   1. QMS Ownership: Own QMS-related activities across the EDS component lifecycle. Set and own the program Design History File (DHF) strategy.
   2. Documentation & Traceability: Develop, maintain, and govern required design, development, verification, and release documentation. Ensure traceability between requirements, design artifacts, implementation, verification, and releases.
   3. Audit Readiness: Coordinate reviews, approvals, and signoffs for quality records. Support audits, assessments, and inspection of readiness activities while maintaining compliance with organizational development processes and regulatory requirements.
   4. Continuous Improvement: Drive continuous improvement of quality processes, templates, and workflows. Ensure component Technical Design Reviews (cTDR/dTDR/eTDR) align with program plans and needs.
2. Product Security & Secure Development
   1. Security Governance: Serve as the Product Security Representative for EDS, ensuring adherence to Secure Development Lifecycle requirements.
   2. Risk Management: Coordinate security reviews, threat modeling, and security risk assessments. Track remediation of vulnerabilities, security findings, and compliance gaps.
   3. Release Validation: Ensure security controls, evidence, and documentation are completed before releases.
   4. Engineering Partnership: Partner with engineering teams to implement secure coding and dependency management practices. Coordinate penetration testing, security scans, SBOM generation, and vulnerability management activities. Track security metrics, remediation SLAs, and compliance status across components.
3. Governance & Program Oversight
   1. Release Readiness: Establish release readiness checklists covering quality and security requirements. Maintain audit-ready records and ensure documentation integrity.
   2. Strategic Liaison: Act as the primary liaison between EDS teams, Quality, Regulatory, and Product Security organizations. Collaborate with Product, Architecture, UX, and Engineering to identify compliance risks and mitigation plans.
   3. Automation: Drive automation of QMS and security compliance processes where practical. Monitor compliance with KPIs and provide status reporting to leadership.

Qualifications

• Experience: 10+ years of experience with Quality Management Systems (QMS) and regulated product development.
• Mandatory: Strong understanding of Secure Development Lifecycle practices.
• Mandatory: Experience coordinating security reviews, threat modeling, vulnerability management, and compliance activities.
• Domain Knowledge: Familiarity with design controls, traceability, audit readiness, and release governance.
• Process & Methodology: Experience in Agile Software Development, including associated concepts, tools, and practices. Ability to drive process improvements and compliance automation initiatives.
• AI Tooling: Experience using AI tools is a must to enhance workflows, optimize compliance checks, or assist in documentation generation.
• Leadership Skills: Strong cross-functional leadership, stakeholder management, and program coordination skills.
• Education: Bachelor's degree in Computer Science, Engineering, or related field.
• Inclusion and Diversity: GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, colour, 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 behaviours: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.

Additional Information

• Relocation Assistance Provided: No
• GE HealthCare: At GE HealthCare, we see possibilities through innovation. We’re partnering with our customers to fulfill healthcare’s greatest potential through groundbreaking medical technology, intelligent devices, and care solutions. Better tools enabling better patient care. Together, we are not only building a healthier future but living our purpose to create a world where healthcare has no limits.