Senior Manager, Product Data Governance & Lifecycle Management

ZOLL Medical•Chelmsford, MA

About The Position

The Senior Manager, Product Data Governance and Lifecycle Management provides strategic and operational leadership for product data, configuration management, document control, and product lifecycle management (PLM) systems throughout the product lifecycle. The role establishes governance, ensures data integrity and traceability, and enables compliant and efficient product development, manufacturing, and sustaining operations across ZOLL’s Acute Care Technology division. The position serves as the division’s business owner for product data governance, configuration management, document control, change control, and PLM processes and systems. It develops governance frameworks and procedures, leads the PLM strategy and roadmap, and ensures product data consistency across PLM, Oracle ERP, CAD, and related systems. The role works across Engineering, Quality, Regulatory Affairs, Manufacturing, Supply Chain, and Information Technology to support regulatory compliance, operational improvement, audit readiness, and business initiatives. The Senior Manager leads geographically distributed teams responsible for document control, change analysis, PLM administration, CAD support, and related functions. It also establishes KPIs, leads training and change management, and provides escalation and operational support for complex product data, configuration, PLM, and change-control issues.

Requirements

Bachelor’s degree; Business, Engineering, Supply Chain Management, or a related field is preferred.
At least 8 years of progressive experience in product development, manufacturing, quality, regulatory affairs, product data governance, configuration management, or PLM leadership within medical devices or another highly regulated industry.
At least 5 years of team management experience.
Direct experience with product lifecycle management systems and processes.
Experience leading change initiatives and improving business processes.
Demonstrated ability to establish, measure, analyze, and drive improvement using operational and compliance KPIs.
Working knowledge of PLM and ERP systems.
Subject matter expertise in configuration management, engineering change control, product structure governance, and controlled documentation.
Strong collaboration, interpersonal, teamwork, and presentation skills.
Strong workload planning, organization, attention to detail, and follow-through.
Working knowledge of part numbering and bill of material (BOM) structuring.
Working understanding of quality system requirements.
Strong understanding of design controls, product lifecycle processes, and quality system requirements within regulated industries.
Ability to influence and drive alignment across Engineering, Quality, Regulatory Affairs, Manufacturing, Supply Chain, and Information Technology.
Strong analytical and problem-solving skills, including the ability to make data-driven decisions.

Nice To Haves

Experience managing managers.
Experience implementing or upgrading enterprise PLM systems.
Experience supporting FDA inspections, ISO audits, and regulated product lifecycle processes.
Experience with Oracle Cloud PLM and ERP.
Experience leading organizational change management and enterprise process transformation initiatives.

Responsibilities

Chair or lead cross-functional governance forums covering product data standards, configuration management practices, PLM governance, and engineering change management.
Serve as the Acute Care Technology business owner for product data governance, configuration management, document control, change control, and PLM processes and systems.
Establish and maintain governance frameworks for item master data, bills of material, product structures and configurations, controlled documents, and lifecycle states.
Own and continuously improve processes and procedures for product data, controlled documentation, configuration, and product changes.
Develop and execute the PLM strategy and roadmap in partnership with Engineering, Quality, Regulatory Affairs, Manufacturing, Supply Chain, and Information Technology.
Monitor enterprise and industry best practices and incorporate applicable practices into product data, configuration, document control, change control, and PLM processes.
Own PLM platform governance, including system administration, workflows, integrations, enhancements, validation activities, user adoption, and overall system effectiveness.
Ensure product data accuracy and consistency across PLM, Oracle ERP, CAD, and related business systems.
Establish, monitor, and report KPIs for data quality, change cycle times, document processing efficiency, system utilization, training effectiveness, and compliance performance.
Lead cross-functional initiatives to standardize and scale processes, improve data quality, reduce cycle times, and support compliance.
Ensure product data, document control, configuration management, and engineering change processes comply with applicable regulatory requirements, company policies, and global regulations.
Maintain inspection and audit readiness through compliant product records, controlled documentation, and change history documentation.
Support internal audits, regulatory inspections, product development, sustaining engineering, manufacturing transfers, and other initiatives involving product data or controlled documentation.
Lead and develop geographically distributed teams responsible for document control, change analysis, PLM administration, CAD support, and related functions.
Establish team objectives and performance indicators for data quality, change cycle time, document control, system performance, training effectiveness, and user adoption.
Lead training, communication, and change management for new processes, system capabilities, and continuous improvement initiatives.
Provide leadership escalation and operational support to resolve complex product data, configuration, PLM, and change-control issues while ensuring business continuity.