Automation Process Engineer

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Regular Full-Time Fort Lauderdale, FL, US

Primary focus will be on the development, characterization, optimization, validation, and production support of manufacturing and test equipment utilized for the manufacture of consumable devices. Familiarity with medical devices and web based technologies in an FDA environment are relevant experiences which apply to this position.

The ideal candidate brings expertise in:

• PLC and HMI programming
• Knowledge of machine vision systems
• Mechanical functions and concepts
• DOE and process optimization
• FDA-regulated equipment and software validation
• Solid understanding of cGMP
• Electrical schematic comprehension and design
• Panel design and assembly
• Servo, pneumatic and hydraulic system knowledge

You’ll be participating in automation projects from concept through production-floor integration while partnering with R&D, Operations, Production, and Maintenance.

• Ability to champion changes across Research and Development and Operations
• Proven track record in the use of Design Of Experiments (DOE) methods to characterize and optimize manufacturing processes
• Expertise in machine control design including electrical schematics, and electrical panel drawings
• Writes detailed protocols to meet quality system requirements and regulatory submissions
• Expertise in developing Programmable Logic Controllers (PLC) and Personal Computer (PC/e.g. OPTO
  22) based machine control and Human Machine Interface (HMI/e.g. Visual Basic) software
• Expertise in developing machine vision applications (Acuity, Cognex, Sherlock, DVT) for the registration and inspection of intermediate and final device manufacture
• Expertise in designing complex mechanical systems in a parametric CAD system such as Solid Works, Solid Edge, Pro Engineer, etc.
• Expertise in creating detail mechanical drawings including Geometric, Dimensioning & Tolerancing (GD&T) standards
• Expertise in creating machine pneumatic diagrams
• Experience in developing and implementing process and software validation plans
• Demonstrated ability to fully develop machine documentation packages including I/O lists, Bills of Materials (BOM), machine operating procedures, preventive maintenance, etc.

• Ability to effectively collaborate in a multi-functional project team environment
• Excellent verbal and written communication
• Experience in developing and managing work plans (Gantt charts)
• Proven track record in successfully coordinating, suppliers in the fabrication and integration of machine components, assemblies, and systems. Demonstrated on-schedule and within budget performance is critical
• Ability and desire to expand one’s technical and leadership skills in an effort to continually increase one’s contribution to the company’s goals and objectives
• Ability to write acceptance criteria for an automation system
• Ability to manage a vendor to design, fabricate, and test a new automation system which can be integrated into our production floor. This involves concept reviews, maintaining schedules, hosting meetings and design reviews

This position must be able to work closely with production and maintenance to install new equipment and keep it running. This involves identifying resources needed, assembling / managing sub-groups to solve machine issues, and leading vendors through any machine improvement designs as separate projects. Also, directly supervise and arrange subordinate supervisors and non-supervisory employees.

To perform this job successfully, an individual must be able to perform each…