Senior Systems Designer - Digital Cardiovascular Ultrasound

GE Healthcare Private Limited; Karnataka; On-site; INR 3,000,000 - 5,400,000; Full time

Job summary

GE Healthcare Private Limited is seeking a Senior Staff Systems Designer to lead end-to-end systems engineering for digital cardiovascular ultrasound products. You will orchestrate requirements, architecture, verification, validation, and risk management across the product lifecycle, guiding teams and ensuring regulatory compliance.

The role requires strong technical judgment, 8+ years in medical device development, and collaboration with global stakeholders to advance product quality and

Qualifications

• 8+ years in engineering roles within medical device or healthcare tech.
• Expertise in system architecture, requirements, risk mgmt, and design control.
• Experience leading cross-functional product development teams and programs.
• Knowledge of FDA, MDR, IEC standards and healthcare quality systems.

Responsibilities

• Lead end-to-end systems engineering for digital cardiovascular ultrasound products.
• Own requirements flow-down, architecture, integration, verification, and validation.
• Drive risk management activities including FMEA and CAPA closures.
• Coordinate with global stakeholders for regulatory submissions and audits.
• Mentor engineering teams and influence program priorities and execution.
• Support manufacturing, service, and post-market activities with root-cause analyses.

Skills

Systems engineering

Regulatory compliance

Cross-functional leadership

Risk management

Medical device development

Education

Bachelor's or Master's in engineering

Tools

AWS

Kubernetes

CI/CD

DevSecOps

Job description

Senior Staff Systems Designer Job Description Summary The Senior Systems Designer of Digital Cardiovascular Ultrasound, responsible for all systems engineering activities throughout the lifecycle of the digital product. The role ensures alignment of customer workflows, product functionality, quality, reliability, serviceability, manufacturability, regulatory compliance, and cost objectives. Key responsibilities include definition and flow-down requirements, system architecture and design, integration, modeling, risk management (FMEA), verification and validation testing, reliability assessment, manufacturing support, and resolution of customer issues. The role applies systems engineering principles to translate requirements into effective product solutions through design trade-off analyses, integration, and verification. This position influences engineering approaches, projects, and programs within the business, driving improvements in product quality, team effectiveness, and operational efficiency. Operating with moderate autonomy, the role requires strong technical expertise, sound judgment, and significant input into priorities, processes, and strategic decisions. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

The Senior Systems Designer of Digital Cardiovascular Ultrasound, responsible for all systems engineering activities throughout the lifecycle of the digital product. The role ensures alignment of customer workflows, product functionality, quality, reliability, serviceability, manufacturability, regulatory compliance, and cost objectives. Key responsibilities include definition and flow-down requirements, system architecture and design, integration, modeling, risk management (FMEA), verification and validation testing, reliability assessment, manufacturing support, and resolution of customer issues. The role applies systems engineering principles to translate requirements into effective product solutions through design trade-off analyses, integration, and verification. This position influences engineering approaches, projects, and programs within the business, driving improvements in product quality, team effectiveness, and operational efficiency. Operating with moderate autonomy, the role requires strong technical expertise, sound judgment, and significant input into priorities, processes, and strategic decisions.

Roles and Responsibilities

• Lead end-to-end systems engineering activities for digital cardiovascular ultrasound products throughout the medical device development lifecycle, from concept through commercialization and post-market support.
• Own the definition, development, and delivery of product features and clinical applications, including requirements management, architecture development, design analysis, integration, verification, validation, and risk management.
• Drive technical risk identification and retirement while ensuring compliance with applicable quality, regulatory, cybersecurity, and safety requirements.
• Lead cross-functional development teams across engineering, clinical, quality, regulatory, product management, manufacturing, service, and marketing organizations.
• Ensure effective requirements flow-down and traceability from customer and clinical needs to subsystem and component-level specifications.
• Conduct system design trade-off analyses and make data-driven decisions that balance performance, reliability, manufacturability, serviceability, scalability, and cost objectives.
• Lead design control activities including FMEA, hazard analysis, verification and validation planning, reliability testing, defect prevention, and corrective and preventive actions (CAPA).
• Serve as the primary systems engineering representative for internal and external audits, regulatory submissions, product reviews, and compliance activities.
• Provide technical leadership and mentoring to systems engineering teams, influencing program priorities, development strategies, and execution plans across multiple product generations.
• Collaborate closely with global stakeholders to resolve complex technical challenges, manage dependencies across subsystems, and ensure seamless product integration and customer satisfaction.
• Support manufacturing, field service, and customer issue resolution activities, driving root cause analysis and continuous product improvement initiatives.

Educational Qualifications

• Bachelor’s or master’s degree in engineering, Computer Science, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related STEM discipline.

Required Qualifications

• Minimum of 8+ years of engineering work experience in product development
• Minimum of 6+ years of experience with systems engineering, product development, and design control processes within the medical device or healthcare technology industry.
• Strong understanding of medical device development lifecycle, requirements management, risk management, verification and validation, and regulatory compliance.
• Experience leading cross-functional product development teams and complex technical programs.
• Knowledge of system architecture, subsystem integration, software-hardware interactions, and clinical workflow development.
• Strong analytical, problem-solving, communication, and stakeholder management skills.

Desired Characteristic s

• Demonstrated experience in systems engineering methodologies in healthcare product development.
• Expertise in FMEA, reliability engineering, and healthcare quality management systems.
• Demonstrated successfully leading new product introductions and multi-generational product development programs.
• Working knowledge of FDA, MDR, IEC 60601, IEC 62304, ISO 14971, and related medical device standards.
• Proven ability to influence technical strategy, mentor engineering teams, and drive execution across global organizations.

Engineering Expectations

• Cloud-native and hybrid cloud/on-premises product development using AWS services.
• Containers, Kubernetes, CI/CD, Infrastructure as Code and production observability.
• Secure engineering, identity and access management, encryption, secrets management and DevSecOps.
• Performance, scalability, availability, reliability, fault tolerance and disaster recovery.
• Automated unit, integration, API, system, performance and reliability testing.
• Strong design, coding, debugging, root-cause analysis and technical documentation practices.
• Integration challenges of third party and second party SaaS solutions.
• Working with AI-DLC and software development acceleration.

Healthcare and Medical Device Context

• Experience in regulated healthcare or medical-device development is required for the Verification Lead and strongly preferred for senior architecture, automation and program roles.
• Strong knowledge on SDLC, PRD process, Risks, FMEAs.
• Awareness of patient-data privacy, cybersecurity and secure handling of clinical information.
• Knowledge of healthcare interoperability standards such as DICOM, HL7 and FHIR.
• Experience with real-time clinical data, device connectivity, patient monitoring or high-availability clinical applications is advantageous.

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.

#EveryRoleIsVital Additional Information Relocation Assistance Provided: No Experience Level Senior Level