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ZOLL Medical

Emergency care medical devices and software

Senior Manager, Product Data Governance & Lifecycle Management

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeRemote in USA$135k - $175k /yrRemote

About the Job

Requirements

  • A bachelor's degree, preferably in Business, Engineering, Supply Chain Management, or a related field.
  • At least 8 years of progressive experience in product development, manufacturing, quality, regulatory affairs, product data governance, configuration management, or product lifecycle management leadership within medical device or other highly regulated industries.
  • At least 5 years of experience managing a team; experience managing managers is preferred.
  • 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 key performance indicators.
  • Working knowledge of product lifecycle management systems and enterprise resource planning systems.
  • Subject matter expertise in configuration management, engineering change control, product structure governance, and controlled documentation.
  • Working knowledge of part numbering and bill of material 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.
  • Experience leading organizational change management and enterprise process transformation initiatives.
  • Strong analytical and problem-solving skills with the ability to make data-driven decisions.

Responsibilities

  • Chair or lead cross-functional governance forums responsible for product data standards, configuration management practices, product lifecycle management governance, and engineering change management.
  • Serve as the Acute Care Technology business owner for product data governance, configuration management, document control, change control, and product lifecycle management processes and systems.
  • Establish and maintain governance frameworks for item master data, bills of material, product structures, product configurations, controlled documents, and lifecycle states to ensure accuracy, integrity, traceability, and regulatory compliance.
  • Own and continuously improve processes and procedures governing product data, controlled documentation, configuration, and product changes.
  • Develop and execute the product lifecycle management strategy and roadmap in partnership with Engineering, Quality, Regulatory Affairs, Manufacturing, Supply Chain, and Information Technology, aligning system capabilities and business processes with organizational and Quality Management System objectives.
  • Monitor enterprise and industry best practices and incorporate applicable practices into product data, configuration, document control, change control, and product lifecycle management processes.
  • Own product lifecycle management platform governance, including system administration, workflows, integrations, enhancement roadmap, validation activities, user adoption, and overall system effectiveness.
  • Ensure the accuracy and consistency of product data across product lifecycle management, Oracle enterprise resource planning, computer-aided design, and related business systems.
  • Establish, monitor, and report key performance indicators related to data quality, change cycle times, document processing efficiency, system utilization, training effectiveness, and compliance performance.
  • Lead cross-functional initiatives to develop standardized, scalable processes that ensure data quality, reduce cycle times, and support compliance.
  • Ensure product data, document control, configuration management, and engineering change processes comply with applicable regulatory requirements, including FDA Quality System requirements, ISO 13485, company policies, and applicable global regulations.
  • Ensure continued inspection and audit readiness by maintaining compliant product records, controlled documentation, and change history documentation.
  • Support internal audits, regulatory inspections, product development, sustaining engineering, manufacturing transfers, and other business initiatives involving product data or controlled documentation.
  • Lead and develop geographically distributed teams responsible for document control, change analysis, product lifecycle management administration, computer-aided design 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 activities supporting new processes, system capabilities, and continuous improvement initiatives.
  • Provide leadership escalation and operational support to resolve complex product data, configuration, product lifecycle management, and change-control issues while ensuring business continuity.

Desired Qualifications

  • Experience implementing or upgrading enterprise product lifecycle management systems.
  • Experience supporting FDA inspections, ISO audits, and regulated product lifecycle processes.
  • Experience with Oracle Cloud product lifecycle management and enterprise resource planning systems.
  • Experience managing managers.

About the Company

ZOLL Medical

Emergency care medical devices and software

ZOLL Medical develops and markets medical devices and software for emergency and critical care. Its products include defibrillators and automated external defibrillators (AEDs), mobile ECG systems, disposable electrodes, temperature management devices, and sleep apnea therapies, all complemented by software that integrates with the hardware to manage and analyze patient data. The products are designed for hospitals, emergency medical services (EMS), and other healthcare facilities worldwide, offering an end-to-end solution that combines hardware and data software. The goal is to improve patient outcomes and boost clinical and operational efficiency through reliable, integrated devices and data-enabled software for emergency and critical care.

Company size
1,001-5,000
Company stage
Acquired
Total funding
$2.2B
Headquarters
Chelmsford, MA
Founded
1980

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