Prinsipal MES Business Analyst - Shockwave Medical

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function

Supply Chain Manufacturing

Job Sub Function

Manufacturing Process Improvement

Job Category

Professional

All Job Posting Locations:

Alajuela, Costa Rica

Job Description

Johnson & Johnson is hiring for a Prinsipal MES Business Analyst to join our team located in Shockwave Medical Costa Rica.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Principal Sustaining MES (Manufacturing Execution Systems) in the medical industry plays a critical role in ensuring the seamless operation, optimization, and continuous improvement of the MES systems within a manufacturing environment. These individual bridges the gap between IT, production, Manufacturing, Supply chain and quality teams to enhance efficiency, compliance, and product quality in a regulated environment such as pharmaceuticals, medical devices, or biotechnology.

Essential Job Functions

• Serve as the primary point of contact for the manufacturing areas for troubleshooting issues related to MES operation.
• Support MES end users/manufacturing areas management with escalation of issues to the correct group.
• Create & maintain standard work, procedures and/or process flow maps for Manufacturing areas team on topics related to MES operation – in compliance with standards.
• Provide training to end-users and support management in conducting end user assessments as needed.
• Monitor Manufacturing areas data for completeness and accuracy – report KPIs to management
• Work closely with Continuous Improvement team, Manufacture engineer, quality, production and supply chain to implement corrective actions for issues in the Manufacturing areas.
• Support all open tickets and provide regular updates to management on the status of items.
• Create and manage change requests (CR/SC) needed to refine processes with new customizations.
• Manage system updates, test & release configuration changes and development of new functionalities, and support future expansion.
• Assist project team in the implementation of project phases. Collaborate with cross-functional teams to ensure alignment of MES implementation and validation activities with project timelines and objectives.
• Stay current with industry trends, regulatory guidelines, and advancements in MES technology to continuously improve implementation and validation processes.
• Support new product development, productivity projects by preparing and executing project implementation plans.
• Support lean initiatives (5S, Kaizen Events, site KPIs, Managing for Daily Improvement, 9 step problem solving, etc.).
• Support compliance activities related FDA (ISO 13485).
  
  

Requirements

• Bachelor’s degree (Computer Science, Computer / Software, industrial, mechanic, Engineering / Industrial or equivalent preferred).
• 10+ years of experience working in an MFG IT environment or equivalent.
• 5+ years of experience working with MES applications or equivalent.
• Experience in designing / developing enhancements in applications.
• Experience in Low Code no code development tools.
• Exposure to managing users and roles.
• Exposure to Reporting platforms (Power BI) is a plus
• Excellent interpersonal and communication skills to communicate effectively at all levels
• Strong attention to detail with the ability to multi-task and prioritize tasks
• Continuous Improvement mindset with superior analytical and problem-solving skills
• Previous experience working in a SCRUM or Agile environment desirable
• Ability to work in a fast-paced environment while managing multiple priorities
• Experience working in FDA regulated environments is a plus