Manufacturing Engineer

4 weeks ago

Westbrook, United States GForce Life Sciences Full time

Manufacturing Engineer - Westbrook, ME

MUST BE ABLE TO WORK ON A W2

Job Title: Manufacturing Controls Engineer

Job 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.

Qualifications

  • 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
  • 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
  • Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
  • 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 architectures is required, including Programmable Logic Controllers (PLCs), Human Machine Interfaces (HMI), Motion Control, Robots, and Vision Systems
  • 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
  • Ability to travel up to 10% of the time

Responsibilities:

  • 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.

Term & Start

  • 3-6- month contract
  • FT, M-F 40hr/week
  • Pay Rate: $35-40/HR (70-80K Annually)
  • Onsite in Westbrook, ME

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