Lead Systems Designer – IoMT Installed Base (IB)

I00M05 Wipro GE Healthcare Private Limited; Bengaluru; Vor Ort; INR 4.000.000 - 7.000.000; Vollzeit

Zusammenfassung

GE HealthCare is seeking a Lead Systems Designer to spearhead the architecture and lifecycle evolution of PCS IoMT products and platforms. You will drive technical strategy, ensure regulatory compliance, and mentor teams across engineering, regulatory, and service functions.

You will collaborate with Product Management, Quality, Cybersecurity, and Operations to translate customer needs into scalable, compliant system solutions while maintaining QMS alignment and design controls.

Qualifikationen

• Bachelor’s or master’s degree in computer science, software engineering, systems engineering, biomedical engineering or a related STEM field.
• 10+ years in software, systems engineering, or product development.
• 3+ years in MedTech or regulated product development environments.

Aufgaben

• 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 enhancements, sustaining engineering, modernization, obsolescence management, and technology refresh.
• Lead investigations of customer, field, quality, and cybersecurity issues, driving root-cause analysis and long-term solutions.
• Collaborate with cross-functional teams to translate customer and business needs into robust system solutions; manage requirements, interfaces, and traceability.
• Drive architectural reviews, trade-off decisions, and implementation strategies across multiple releases.
• Ensure compliance with QMS, Design Control, Risk Management, CAPA and regulatory requirements.
• Mentor teams on systems engineering best practices, risk analysis, verification, and validation.

Kenntnisse

Systems Engineering

System Architecture

QMS

Design Controls

Risk Management

PLM

CAPA

Change Control

Ausbildung

Bachelor’s/Master’s in STEM

Jobbeschreibung

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

In this role, you will: 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 world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Additional Information

Relocation Assistance Provided: No

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.