Principal MES Support Lead (IT)
Description
Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical 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.
Description
Position Overview
The Senior MES (Manufacturing Execution Systems) Support Lead 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. This individual, bridges the gap between IT, production, 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 shop floor for troubleshooting issues related to MES operation.
- Support MES end users/shop floor management with escalation of issues to the correct group.
- Create & maintain standard work, procedures and/or process flow maps for shop floor 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 shop floor data for completeness and accuracy – report KPIs to management
- Work closely with Continuous Improvement team to implement corrective actions for issues in the shop floor.
- Coordinate all open support tickets and provide regular updates to management on the status of items.
- Create and manage change requests (CR) 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 project managers and 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, Rapid Improvement Events, site KPIs, Managing for Daily Improvement, 9 step problem solving, etc.).
Requirements
- Bachelor’s degree (Computer Science, Computer / Software Engineering or equivalent preferred)
- 10+ years of experience working in an MFG IT environment.
- 5+ years of experience working with MES applications.
- Desired experience in designing / developing enhancements in MES applications.
- 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
Benefits
Shockwave Medical offers competitive total compensation packages in line with market requirements.