Product Program Manager RAD and Change Management

GE Healthcare

8+ yrs Bengaluru Full Time Hybrid (office + remote)
GE Healthcare logo
Posted : today
Actively hiring

Job description

Spearhead product program management for RAD subsystem products, focusing on X-Ray Tubes and X-Ray Generators for mobile and fixed radiography systems. This role involves driving engineering design changes and overseeing the product lifecycle for these critical components at GEBEL. You will be instrumental in managing the performance of the installed base, enhancing quality, reliability, regulatory adherence, lifecycle management, cost-effectiveness, and delivery. Leveraging installed base data is key to establishing robust reliability targets and implementing Design for Reliability principles for new product introductions.

GE HealthCare is a global leader in medical technology and digital solutions, dedicated to creating a world where healthcare has no limits. We empower individuals to achieve their ambitions, transforming innovative ideas into impactful, world-changing realities within an organization that values every voice and contributes to a healthier planet.

Responsibilities

Oversee the field and factory performance of RAD Tubes and Generators, prioritizing quality, reliability, compliance, cost, and delivery. Monitor field performance and Early Life Failure (ELF) trends using key metrics and present product performance in global reviews. Analyze field and reliability data through statistical methods, including Weibull analysis and life estimation, to pinpoint risks and areas for enhancement. Lead investigations for customer complaints and field failures, encompassing autopsy, failure analysis, RCA, corrective actions, and product fixes.

Collaborate with System Engineering, Field Engineering, and Service teams for technical troubleshooting, product training, and resolving field issues. Support New Product Introductions (NPIs) by setting reliability targets, utilizing installed base performance, failure trends, and reliability insights. Contribute to Risk Management activities, including DFMEA/PFMEA, design reviews, Verification & Validation, and risk assessments. Maintain Technical Files, Risk Management, and Design Control documentation to ensure QMS compliance and audit readiness. Drive product lifecycle initiatives for obsolescence, product enhancements, regulatory compliance, and Variable Cost Productivity (VCP).

Chair Engineering Change Control Board (ECCB) reviews to ensure timely, rigorous, and QMS-compliant engineering changes for X-Ray Tubes and Generators. Act as the Engineering Business Process Owner (BPOC) for Supplier Change Requests (SCRs), conducting initial impact assessments, coordinating cross-functionally, and assigning change owners. Represent Engineering during QMS, regulatory, certification, and customer audits, and support Quality Management Reviews. Partner with Manufacturing, Quality, Regulatory, Service, Supplier Quality, and Sourcing to elevate product quality, manufacturing yield, reliability, and cost. Apply statistical methodologies to foster structured problem-solving, RCA, and continuous improvement.

Qualifications

A Bachelor's, Master's, or PhD in Electrical and Electronics or Mechanical Engineering is required, coupled with 8+ years of engineering experience, ideally within medical devices, medical imaging, X-Ray products, or other highly regulated sectors. Essential experience includes Installed Base Engineering, Engineering Change Management, Design Controls, Risk Management, and Product Lifecycle Management. A strong background in field performance monitoring, failure analysis, RCA, reliability engineering, and statistical data analysis is crucial.

Familiarity with Weibull analysis, B10/B50 life estimation, reliability target setting, and Design for Reliability is necessary. Working knowledge of medical-device and X-Ray Tube/Generator product safety standards, QMS requirements, and regulatory compliance, including IEC 60601, ISO 13485, and ISO 14971, is essential. Proficiency with QMS and Design Control tools such as DFMEA/PFMEA, Risk Management, Design Reviews, Verification & Validation, ECR/ECO, CAPA, and configuration/change management is expected.

Experience in Supplier Change Management, obsolescence, product quality improvement, and manufacturing/yield improvement is beneficial. Familiarity with structured problem-solving tools like 5-Why, Fishbone, and Pareto analysis, alongside statistical analysis, is required. A Six Sigma Green Belt certification is preferred.

Key attributes include strong technical leadership, systems thinking, and structured problem-solving skills. The ability to translate field and reliability data into actionable product improvements and NPI reliability targets is vital. Candidates should possess strong analytical, statistical, and risk-based decision-making capabilities, with the ability to influence and collaborate effectively across global cross-functional teams. A strong execution focus on quality, reliability, compliance, cost, and delivery, combined with excellent communication, stakeholder management, and technical documentation skills, is expected. This role requires a self-driven, results-oriented individual committed to continuous improvement and execution excellence.

Essential Skills

Product Lifecycle ManagementEngineering Change ManagementDesign ControlsRisk ManagementField Performance MonitoringFailure AnalysisRoot Cause Analysis (RCA)Reliability EngineeringStatistical Data AnalysisWeibull AnalysisB10/B50 Life EstimationDesign for Reliability (DFR)Medical Device StandardsX-Ray Tube/Generator Product SafetyQuality Management System (QMS)Regulatory ComplianceIEC 60601ISO 13485ISO 14971DFMEAPFMEAECR/ECOCAPAConfiguration ManagementSupplier Change ManagementObsolescence ManagementProduct Quality ImprovementManufacturing Yield ImprovementStructured Problem SolvingSix Sigma

Good to Have

Six Sigma Green Belt

Highlights

  • Actively hiring

More Details

RoleProduct Program Manager RAD and Change Management
IndustryMedical Devices, Healthcare
DepartmentProduct Management, Program Management
Employment TypeFull Time, Hybrid (office + remote)

About the Company

GE Healthcare logo

GE Healthcare

Medical Devices

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