Manufacturing Systems Specialist

Location: Cheswick, PA

Cardiac Management Solutions

The Cardiac Management Solutions division of ZOLL Medical Corporation develops products to protect and manage cardiac patients, including the LifeVest® wearable cardioverter defibrillator (WCD), the ZOLL cardiac monitor, and associated technologies. Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need. To date, the LifeVest WCD has been worn by hundreds of thousands of patients and saved thousands of lives. ZOLL has been Pittsburgh’s Manufacturer of the Year, one of Western PA’s Healthiest Employers, and even one of Pittsburgh’s Coolest Offices. But it’s our unique opportunity to impact people’s lives that makes ZOLL the ideal place to build your career.

Job purpose

Uses production process, manufacturing systems knowledge, and problem solving skill sets to identify and resolve production issues, improve process operations and affect positive change.

Uses knowledge of compliance and cGMP production processes to define and sustain digital processes and improvement initiatives within production operations.

Duties and responsibilities

  • Models operational process requirements in Manufacturing Execution Systems (MES)

  • Collaborates cross functionally to develop engineering documents and MES requirements (PFMEAs, Configuration Documents, procedure SOPs, etc.)

  • Develop and maintain naming conventions and best practices for data objects

  • Models data collections and transactions for analysis and trending

  • Maintains alignment of manufacturing systems processes with all quality system requirements

  • Understands and incorporates ERP transactions and MES touchpoints during process development and support

  • Defines and executes testing and validation plans

  • Creates ad hoc queries and performs data analysis

  • Maintains appropriate BOM configurations within the MES

  • Identifies user requirements and opportunities for system customization

  • Participates in the planning, design, implementation, integration, and validation of manufacturing system upgrades

  • Quantifies business impact of proposed and active projects

  • Gathers project requirements

  • Builds and maintains project schedule

  • Coordinates resource allocation for projects

  • Documents MES changes through change control process

  • Identifies and regularly communicates with project stakeholders

  • Resolves or escalates project constraints and roadblocks

  • Leads project launch and post-launch support activities

  • Drives accountability for project completion cross-functionally

  • Leads lessons learned sessions for projects

  • Trains users to system functionality and process changes

  • Fulfills an on call schedule for operations support

  • Advises business team on non-standard processing among systems

  • Resolves IT Tickets for MES

  • Follows and documents work processes and standard operating procedures

  • Supports root cause analysis and corrective action for process failures

  • Designs operational use of in-process reporting, supporting User Interaction and functionality development with report developers

  • Uses MES models to define report requirements

  • Trains others to system support processes and documents

  • Collaborates with software vendors to resolve issues

  • Reviews change orders for potential systemic impact

  • This position assumes and performs other duties as assigned

Qualifications

  • High School Diploma or equivalent required

  • Associate degree in Computer Science, Manufacturing Engineering, Industrial Engineering, or a related discipline and two years related experience preferred

  • Experience training others on technical systems and processes required

  • Project Management experience required

  • SQL Queries/Data Selection, Joins, Complex Queries, Data Definition required

  • Excellent verbal and written communications skills and the ability to interact professionally with a diverse group of executives, managers, engineers, and production personnel

  • Strong skills in presentation; documentation of process and workflows

  • Strong skills in Microsoft Office Suite (Excel, Power Point, Project, Word) required

  • One year experience using relational databases required

  • Demonstrated experience collaborating with and engaging cross-functional teams

  • Experience applying cGMP and Lean Concepts required

  • Experience with medical device manufacturing and/or FDA regulated environment preferred

  • Agile/Scrum Experience preferred

  • Configuration management experience preferred

  • Two years experience supporting ERP/MES processes and procedures preferred

  • Object based programming preferred

Working conditions

  • The noise level in the work environment is usually quiet.

Physical requirements

  • While performing the duties of this Job, the employee is regularly required to sit and talk or hear.  The employee is occasionally required to stand and walk. 

Supervisory responsibility

No Direct Supervisory Responsibility

AAP/EEO Statement

ZOLL is committed to fostering an inclusive workplace, where unique identities, backgrounds, cultures, perspectives and experiences are respected and valued.

Equal Opportunity Employer – Disability and Veteran

ZOLL now mandates COVID vaccinations subject to legal exemptions.

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