Manufacturing Operator

SUMMARY: Responsible for the accurate and compliant manufacture of various products by utilizing a variety of semi-automated and automated equipment and processes. Must be regular and punctual in attendance and adhere to all company policies.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:

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  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 basic troubleshooting and maintain workspace and equipment cleanliness.
• Adhere to strict safety regulations of the company; maintain a safe, clean and organized work area, and ensure that others are doing the same.
• 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.
• Understand and perform manufacturing processes using Manufacturing Process Instructions (MPI’s); record data on lot history records (LHR’s) in collaboration with manufacturing, quality, and R&D.
• 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 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.
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA and applicable regulatory regulations.
• Support the Quality System and Quality Policy. Be aware of Quality System procedures and requirements, including regulatory requirements and training requirements for position activities. Inform responsible personnel of concerns involving product quality
• Perform job functions in a safe and effective manner
• Other duties as assigned

EDUCATION/EXPERIENCE:

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  HS diploma and a minimum of 5 years related experience in the medical device industry.

• Knowledge of and exposure to product manufacturing, testing, and data collection.

• Should possess strong math skills.

• Familiar with GMP, GDP procedures and requirements.
• Ability to work independently or in a team setting required.

• Familiar with manufacturing equipment (hot boxes, adhesives, soldering, bonding, fuse joining).
• Familiarity with testing: tensile, simulated use testing, or tests related to assigned projects.
• Good written and verbal communication skills.
• Computer skills, including knowledge of Microsoft office products.
• Good interpersonal skills, effective interaction with Operations and other departments

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