Manufacturing Controls Engineer

Job Title: Manufacturing Controls Engineer
Duration: 4+ Months (Possibility of extension)
Location: Westbrook, Maine (04092)
Shift: 8 am - 5 pm (Mon-Fri)

Summary
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.

Essential Duties and Responsibilities include the following. Other duties may be assigned.
* Process development, equipment specification, acquisition and implementation.
* Evaluation of machine logic and controls to 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.
* Suggests and supports 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, and 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 process 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.

Supervisory Responsibilities
This position has no direct supervisory responsibilities.
Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable
accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience
Bachelor's degree (BS) in engineering or equivalent combination of education and experience.
Minimum 3 years engineering experience in a manufacturing environment
Experience working in a GMP, FDA, ISO and USDA regulated environment preferred

Language Skills
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 general public.

Mathematical Skills
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.

Reasoning Ability
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.

Technical Skills
Previous experience with common manufacturing automation technologies and architectures is required. This includes but is not limited to:
* Programmable Logic Controllers (PLC's) (Allen Bradley Logix5000 experience preferred)
o Ability to read and troubleshoot existing ladder logic.
o Ability to generate new ladder logic for the sequencing of complex manufacturing tasks.
* Human Machine Interfaces (HMI) (Allen-Bradley Factory Talk View experience preferred)
o Ability to modify and troubleshoot existing user interfaces.
o Ability to design and implement new user interface functionality.
* Motion Control to include Servo Drives, VFD's and Stepper Drives.
o Ability to troubleshoot and tune control loops.
* Robots (Staubli and/or Epson experience preferred)
o Ability to modify robot programs and taught positions.
o Ability to sequence new robot paths and functions.
* Vision Systems (Cognex and/or Keyence experience preferred)
o Ability to troubleshoot existing vision inspection applications.
o Ability to design new systems to include lens and lighting selection.
o Ability to create robust inspection logic for the disposition of product.
* Electrical Aptitude
o Ability to read and trace machine control systems from electrical prints
o Ability to troubleshoot common machine control hardware (relays, fuses, breakers, etc.)
o Ability to generate and modify electrical prints to support controls upgrade and integration.

Other Skills and Abilities
* 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, hand and power tools
* Must be able to meet deadlines while working on multiple projects
* Familiarity with cGMP and ISO 13485 regulations and practices is desired
* Familiarity with a variety of material testing and measuring methods