Manufacturing Operator III

• Operate manufacturing and packaging equipment under company SOP and GMP guidelines.
• Work with in-house and contract manufacturers to ensure products are manufactured in accordance with product plans, quality, and regulatory requirements.
• Interface and work with manufacturing and engineering personnel to understand product requirements, as well as to identify and implement process improvements.
• Perform troubleshooting and maintain workspace and equipment cleanliness.
• Certified on at least 6 processes in the work center; can be a combination of Moderate, Easy and/or Critical, including certified expert status on 2 Critical processes.
• Adhere to strict safety regulations of the company; maintain a safe, clean and organized work area, and ensure that others are doing the same.
• Understand and perform manufacturing processes using Manufacturing Process Instructions (MPI’s)
• Record data accurately on lot history records (LHR’s) in collaboration with manufacturing, quality, and R&D.
• Must be regular and punctual in attendance and adhere to all company policies.
• Responsible for learning and adhering to safety requirements of manufacturing processes, equipment, handling of chemicals and materials, and applying that knowledge during routine operations.
• Accurately use computerized operating systems to run and monitor manufacturing equipment as required.
• Work under supervision to set up and operate a variety of equipment to produce materials and assemblies.
• Monitor and record critical process parameters and ensure that proper documentation and GMP GDP guidelines are followed.
• Participate in manufacturing team meetings to ensure communication between members.
• Provide feedback to assist in the development of new processes or test procedures.
• Support the building of engineering prototypes and products used for preclinical & clinical evaluations.

• HS diploma and a minimum of 2-3 years related experience in the medical device industry.  

• Knowledge of and exposure to product manufacturing, testing, and data collection.
• Familiar with GMP, GDP procedures and requirements.
• Ability to work independently or in team setting required.
• Ability to train others to processes and procedures.
  Strong working knowledge of manufacturing equipment (i.e. hot boxes, adhesives, soldering, bonding, fuse joining).
  Familiarity with testing: tensile, simulated use testing, or tests related to assigned projects is a plus.
• Good hand dexterity and the ability to work with small components.
• Good written and verbal communication skills.
• Computer skills, including knowledge of Microsoft office products.
• Good interpersonal skills, effective interaction with Operations and other departments

Last updated on Sep 24, 2024