Acute Care Technology
Responsible for managing all Product Lifecycle Management (PLM) functions, systems, and staff within the Acute Care Technology division of ZOLL Medical Corporation. Overall ownership of the teams, systems, and workflows that governs product data, engineering change processes, and product structures at ZOLL.
Essential Functions- Lead cross-functional collaboration with stakeholders, employees, suppliers, and internal customers to ensure effective execution of PLM processes, alignment on business requirements, and successful deployment of process improvements and system changes.
- Provide leadership and mentoring to the hybrid team members across multiple time zones and locations including Change Analyst Manager(s), PLM Administrator(s), Computer Aided Drafting (CAD) Lead(s); must perform as a hands-on contributor, as necessary.
- Lead the training and support of ZOLL employees on change control requirements and PLM system capabilities, collaborating with stakeholders and internal customers to drive adoption, continuous improvement, and successful implementation of business process and system enhancements.
- Set team and individual goals and KPI's which align to business and department objectives, fostering the execution of goals through coaching and mentoring
- Identify best practices for configuration and change control across ZOLL. Edit, modify, and improve PLM system and Standard Operating Procedures (SOPs) to implement throughout the organization.
- Lead compliance activities related to the Quality Management System (QMS) in line with international and domestic regulations, business process improvements, and improved end user engagement.
- Assist during external audits by regulatory bodies (e.g. FDA, Notified Body, California State Department of Public Health, Internal) as required.
- Support product development project documentation to ensure compliance with regulatory and internal QMS requirements.
- Accountable for Item Master data in PLM and Oracle ERP system.
Required/Preferred Education and Experience- Bachelor's Degree Business, Engineering, Supply Chain Management, or a related field required
- 8+ years' experience with Manufacturing, Quality, Regulatory, or product development role in the medical device industry required
- 5+ years' experience managing a team, managing managers preferred preferred
- Direct experience with product lifecycle management systems and processes required
- Proven track record of managing and improving business processes required
Knowledge, Skills and Abilities- Ability to utilize/develop tools for creation and management of KPIs
- Working knowledge of Product Lifecycle Management and Oracle ERP systems
- Subject Matter Expert (SME) for Configuration and Change Control
- 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 FDA current good manufacturing practices (cGMP)
Physical DemandsThe 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
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The annual salary for this position is:
$125,000.00 to $175,000.00
This position is eligible for an annual bonus in accordance with the company's bonus plan. 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.
