Manufacturing Controls Engineer II Job at Gateway Recruiting, INC., Westbrook, ME

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  • Gateway Recruiting, INC.
  • Westbrook, ME

Job Description

Job Description

Job Description

Job Summary:

This role will be responsible for supporting product development from concept through sustained manufacturing of FDA-regulated products. Completion of process development, equipment acquisition and leadership of supporting development partners. Experience with manufacturing processes, quality/cost savings initiatives and implementation of engineering principles while assuring compliance with cGMP, quality, and safety standards.

 

Job Responsibilities:

  • Process development, equipment specification, acquisition, and implementation.
  • Evaluation of machine logic and controls troubleshoot equipment and identify process improvement opportunities.
  • Integration of controls hardware and software into new and existing manufacturing equipment.
  • Design of experiments, validation, completion of testing and analysis of data.
  • Suggest and support new methods or materials for continual improvement of quality and efficiency.
  • Analyzes current equipment for process suitability and provides detailed plans for improvement.
  • Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, procedures and other technical documents to ensure compliant, efficient, and safe procedures.
  • Works with other engineers and technicians in developing solutions and improvements in materials, equipment, and processes as necessary.
  • Actively participates in teams as necessary to ensure continual improvement, safety and compliance.
  • Lead cross-functional project teams and coordinate activities.

Measures of Performance:

  • Appropriate process and equipment definition.
  • Quality of communication and documentation
  • Time management and project metrics.
  • Implementation of core engineering principles.

 

Qualifications:

Required:

  • Bachelor's degree (BS) in engineering or equivalent combination of education and experience.
  • Minimum 3 years of engineering experience in a manufacturing environment
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
  • Ability to write reports, business correspondence, and procedure manuals.
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
  • 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.
  • Previous experience with common manufacturing automation technologies and architecture is required.
  • Must be able to work on problems of diverse scope where analysis of the problem requires evaluation of obscure or unknown data.
  • Must be able to use precision measuring equipment, and hand and power tools.
  • Must be able to meet deadlines while working on multiple projects.
  • Programmable Logic Controllers (PLC’s) (Allen Bradley Logix5000 experience
    • Ability to read and troubleshoot existing ladder logic.
    • Ability to generate new ladder logic for the sequencing of complex manufacturing tasks.
  • Human Machine Interfaces (HMI) (Allen-Bradley Factory Talk View experience
    • Ability to modify and troubleshoot existing user interfaces.
    • Ability to design and implement new user interface functionality.
  • Motion Control to include Servo Drives, VFD’s and Stepper Drives.
    • Ability to troubleshoot and tune control loops.
  • Robots (Staubli and/or Epson experience preferred)
    • Ability to modify robot programs and taught positions.
    • Ability to sequence new robot paths and functions.
  • Vision Systems (Cognex and/or Keyence experience preferred)
    • Ability to troubleshoot existing vision inspection applications.
    • Ability to design new systems that include lens and lighting selection.
    • Ability to create robust inspection logic for the disposition of products.
  • Electrical Aptitude
    • Ability to read and trace machine control systems from electrical prints.
    • Ability to troubleshoot common machine control hardware (relays, fuses, breakers, etc.)
    • Ability to generate and modify electricity.

Preferred:

  • Experience working in a GMP, FDA, ISO, and USDA regulated environment.
  • Familiarity with cGMP and ISO 13485 regulations and practices is desired.
  • Familiarity with a variety of material testing and measuring methods.

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