Cleanroom Assembly Packing Operator

Integra LifeSciences•Mansfield, MA
•$19 - $25

About The Position

The Manufacturing Operator 1 (Cleanroom Assembly Packing Operator) uses equipment, including computer-controlled equipment, to assemble and test components and products, and operates various manufacturing equipment. The role assembles precision neurosurgical perforators and related medical devices in a controlled cleanroom environment, following detailed work instructions and engineering specifications. The operator performs production and inspection work according to standard operating procedures (SOPs) and Good Manufacturing Practices (GMPs), maintains accurate manufacturing records, and follows applicable safety, environmental, ISO, FDA, and company requirements. The role also contributes to maintaining the production area, coordinating with support teams, and improving manufacturing processes.

Requirements

  • High school diploma, G.E.D., or equivalent.
  • Basic computer skills.
  • Ability to work independently and as part of a team.
  • Ability to communicate effectively in English by reading, writing, and speaking.
  • Basic math skills, including addition, subtraction, multiplication, division, percentages, and decimals.
  • Ability to stand and/or walk more than 80% of the time.
  • Ability to lift up to 25 pounds and to stand and sit for extended periods with repetitive motion.

Nice To Haves

  • At least 1 year of experience in production, operations, manufacturing, or a related discipline in a cleanroom environment is preferred.
  • Experience in medical device manufacturing is preferred.
  • Experience working in a GMP or other regulated environment is preferred.

Responsibilities

  • Assemble and test components and products using manufacturing equipment, including computer-controlled equipment.
  • Assemble precision neurosurgical perforators and related medical devices in a controlled cleanroom environment according to work instructions and engineering specifications.
  • Perform dimensional and visual inspections according to print specifications, including First Article inspections.
  • Perform operations according to SOPs and GMPs, maintaining quality, productivity, and dependability.
  • Record and enter required information into manufacturing documentation and computers, including quality inspection data and individual training records.
  • Follow applicable federal, state, local, and company Health, Safety, and Environmental regulations, policies, and procedures, as well as ISO and FDA requirements; complete applicable training.
  • Communicate problems and opportunities to a supervisor, technician, or engineer in a timely manner.
  • Perform required preventative maintenance tasks.
  • Maintain a clean, orderly, and safe work environment and equipment.
  • Participate in team-based process improvement activities and suggest manufacturing improvements.
  • Help maintain production-area supplies.
  • Coordinate activities with other manufacturing support areas.

Benefits

  • Medical insurance
  • Dental insurance
  • Vision insurance
  • Life insurance
  • Short- and long-term disability insurance
  • Business accident insurance
  • Group legal insurance
  • 401(k) savings plan
  • Employees may be eligible for bonus, commission, equity, or other variable compensation.
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