Acute Care Technology
At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.
At ZOLL, you won't just have a job. You'll have a career—and a purpose.
Join our team. It's a great time to be a part of ZOLL!
Job Summary
The Senior Manager, Product Data Governance and Lifecycle Management, provides strategic and operational leadership for product data, configuration management, document control and PLM systems throughout the product lifecycle. The role is responsible for establishing governance, ensuring data integrity and traceability, and enabling compliant and efficient product development, manufacturing and sustaining operations across the organization.
Essential Functions
- Chair or lead cross-functional governance forums responsible for product data standards, configuration management practices, PLM governance, and engineering change management.
- Serve as the ACT 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, 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 PLM 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 ACT product data, configuration, document control, change control, and PLM processes, as appropriate.
- Own PLM 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 PLM, Oracle ERP, CAD, and related business systems.
- Establish, monitor, and report key performance indicators (KPIs) 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, 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 activities supporting 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.
Required/Preferred Education and Experience
- Bachelor’s degree, preferably in Business, Engineering, Supply Chain Management, or a related field.
- 8+ years of progressive experience in product development, manufacturing, quality, regulatory affairs, product data governance, configuration management, or PLM leadership within the medical device or other highly regulated industries.
- 5+ years’ experience managing a team; managing managers preferred.
- Direct experience with product lifecycle management systems and processes
- Experience leading change initiatives and improving business processes.
- Experience implementing or upgrading enterprise PLM systems preferred.
- Experience supporting FDA inspections, ISO audits, and regulated product lifecycle processes preferred.
Knowledge, Skills and Abilities
- Demonstrated ability to establish, measure, analyze, and drive improvement using operational and compliance KPIs
- Working knowledge of Product Lifecycle Management systems and ERP systems; Experience with Oracle Cloud PLM & ERP preferred
- Subject Matter Expert (SME) in configuration management, engineering change control, product structure governance, and controlled documentation
- Work collaboratively with a strong bias for continuous improvement
- Strong interpersonal, teamwork, presentation, and collaboration skills
- Strong workload planning skills, 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
- Experience leading organizational change management and enterprise process transformation initiatives
- Strong analytical and problem-solving skills with the ability to make data-driven decisions
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Standing - Occasionally
- Walking - Occasionally
- Sitting - Constantly
- Talking - Occasionally
- Hearing - Occasionally
- Repetitive Motions - Frequently
ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.
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The annual salary for this position is:
$135,000.00 to $175,000.00
Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.
Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee’s primary work location.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.
ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.