Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations.
*Other duties may be assigned.
This role will support manufacturing assembly lines equipment performance and their improvements.
Will be responsible to identify and implement solutions for downtime reduction and equipment malfunctions.
Project management towards solutions to be implemented.
Responsible for coaching and transfer of knowledge for automation sub-systems and systems.
Requirements
Bachelorâs degree in Mechanical, Electrical, or Chemical Engineering.
5+ years of experience in a regulated industry (medical device, pharmaceutical, biotech, insurance, hospital, or health system).
Strong project management experience.
Expertise in automation systems and subsystems integration.
Proficiency in R, SQL, BASH, and Linux.
Advanced automation skills and equipment troubleshooting (electrical & mechanical).
Proficiency with revision control systems (Git, GitLab).
Experience with MES and big data manipulation (preferably SPARK).
Strong communication skills; ability to translate technical concepts for non-technical audiences.
Willing to work 100% on-site in Ponce, Puerto Rico.
Preferred Qualifications:
Experience with process validation, computer/software validation, and equipment validation.
Familiarity with supplier change request management.
Experience in acceptance testing for new equipment/automation.
Knowledge of MTCâs equipment integration architecture and tools such as Ignition and Kepware.
Demonstrated ability to analyze, synthesize, and present complex data from multiple sources.
Proficiency in Microsoft Word, Excel, and PowerPoint.
Strong attention to detail and ability to comply with written SOPs and documentation standards.
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