Automation Process Engineer

Trividia Health, Inc.Fort Lauderdale, FL
Onsite

About The Position

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.

Requirements

  • 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.
  • Expertise in developing Programmable Logic Controllers (PLC) and Personal Computer (PC/e.g. OPTO22) 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 SolidWorks, SolidEdge, Pro Engineer, etc.
  • Expertise in creating detail mechanical drawings including Geometric, Dimensioning & Tolerancing (GD&T) standards.
  • Expertise in creating machine pneumatic diagrams.
  • 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 to write acceptance criteria for an automation system.
  • B.S. in Mechanical Engineering, Industrial Engineering, or Electrical Engineering.
  • 10 years of experience in designing and developing complex automation cells for prototype and production process equipment.
  • Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
  • Ability to write speeches and articles for publication that conform to prescribed style and format.
  • Ability to effectively present information to top management, public groups, and/or boards of directors.
  • Ability to write clear, concise reports and procedures.
  • Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
  • Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Nice To Haves

  • Familiarity with medical devices and web based technologies in an FDA environment.
  • Six Sigma or Lean Manufacturing certification.

Responsibilities

  • Development, characterization, optimization, validation, and production support of manufacturing and test equipment.
  • Champion changes across Research and Development and Operations.
  • Writes detailed protocols to meet quality system requirements and regulatory submissions.
  • Develops and implements process and software validation plans.
  • Fully develop machine documentation packages including I/O lists, Bills of Materials (BOM), machine operating procedures, preventive maintenance, etc.
  • Work closely with production and maintenance to install new equipment and keep it running.
  • Identify resources needed, assemble / manage sub-groups to solve machine issues, and lead vendors through any machine improvement designs as separate projects.
  • Directly supervise and arrange subordinate supervisors and non-supervisory employees.
  • 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.
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