Smart Manufacturing Engineer

POSITION: Smart Manufacturing Engineer

JOB LOCATION: El Lago, TJ, Mexico

POSITION DESCRIPTION:

In this exciting role as a Sr. Systems Engineer, Deployment, you will be responsible for the deployment and integration of digital tools to support manufacturing Operations. The ideal candidate will have experience with automation in manufacturing, including PLC programming, and familiarity with high-level programming languages such as Python and C#, in addition to knowledge of Industry 4.0 technologies like IIoT sensors. Additionally, proficiency or familiarity with SQL for relational databases is required. The candidate must have strong problem-solving and analytical skills in addition to excellent written and oral communication competencies. In addition, the engineer will be responsible for ensuring the validation of processes, equipment, and tools used in the manufacturing of medical devices. This role requires a strong understanding of process validation and engineering documentation. This role involves collaboration with cross-functional teams to drive innovation and efficiency in manufacturing operations.

POSITION RESPONSIBILITIES:

The Sr. Systems Engineer, Deployment will lead and help in the deployment and integration of Digital tools such as OEE, KPI Dashboards, Production Tracker, and/or future apps within a customized platform. This role will lead the corresponding data collection from automated equipment controller, manual operator interfaces and interfaces to other Manufacturing Systems like Manufacturing Execution System (MES) and Statical Process Control (SPC); and will act as SME for all Digital tools, liaison with IT and key stake holders, and will lead all deployment activities, with in-house or third-party software development teams who will develop Digital Performance Management tools.

Responsibilities may include the following and other duties may be assigned.

• Ensure that system-level requirements are understood, successfully implemented, and monitored to increase efficiency.
• Act as the technical lead on projects and interface with technical stakeholders regarding the solution/application deployment.
• Works with team(s) that design, develop, troubleshoot, and debug software programs for enhancements and maximize new products.
• Determine hardware compatibility and/or influence design.
• Collaborate with cross-functional teams to determine customer and product software design requirements
• Generate systems software engineering policies, standards, and procedures. |
• Ensure that system improvements are successfully implemented and monitored to increase efficiency.
• Gather specific requirements and suggest solution customization per the plant requirements. Support the entire application lifecycle (concept, design, test, release, and support) during the application customization phase.
• Work with other team members such as Product Owners, QA and process SMEs to assess risk during three project phases (project initiation, pre-validation test assessment and post-validation test assessment)
• Play a part in guiding and supporting plant teams on machine connectivity and data acquisition activities, and act as a liaison to manufacturing leaders and teams.
• Conduct process validation activities, including installation and operations qualifications.
• Develop and update Manufacturing Process Instructions (MPIs) to ensure alignment with current practices.
• Review department specifications and process documentation to ensure compliance with FDA regulations and internal quality policies.
• Communicate status updates to key stakeholders.
• Candidate must be capable of recognizing factors that could negatively affect project timelines/deliverables and effectively communicate the impact to the direct manager.
• Provide training to key plant personnel on the Industry 4.0 tools and technologies.

DESIRED/PREFERRED QUALIFICATIONS:

• Bachelor of Science degree with Computer Science, Information Technology or equivalent.
• Minimum of 5 years of relevant experience in full-stack development, or an advanced degree with a minimum of 2 years of relevant experience.
• Strong understanding of backend technologies (e.g., .NET Core, Python, C#).
• Experience using SQL and data modelling to support software solutions.
• Experience with cloud services (AWS, Azure, Google Cloud) preferred.
• Experience using MES software solutions such as Factory Works, Critical Manufacturing.
• A working knowledge of IIoT and Industry 4.0 technologies and practices
• Proven experience in process validation within a regulated industry.
• Ability to create and update process layouts, models, and documentation.
• Excellent communication, interpersonal, analytical, problem-solving, and project management skills.