Medical Device Assembler

7 days ago


Danvers, Massachusetts, United States Lighthouse Professional Services Full time
Job Summary

The Cleanroom Production Associate II will be responsible for assembling, inspecting, and testing high-quality medical devices in a controlled manufacturing environment.

Key Responsibilities
  • Process polymer materials to compose, test, or apply on medical devices per approved manufacturing procedures.
  • Assemble plastic and metal components into medical devices in accordance with approved manufacturing procedures.
  • Perform in-process quality checks on subassemblies and finished product.
  • Utilize small hand tools, calibrated instruments, measurement equipment, microscopes, and test fixtures.
  • Participate in line meetings as needed.
  • Work with engineers and technicians to resolve line issues and suggest improvements.
  • Maintain clean room integrity by using proper attire and adherence to clean room environment practice and procedures.
  • Fully understand and maintain accurate records/documentation related to quality, work in progress, test results, labor, and special projects.
  • Apply workstation practices and line clearance in daily activities.
  • Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, and FDA regulations.
Requirements
  • High School Graduate or equivalent manufacturing experience.
  • Must have good hand-eye coordination, experience with microscopic assembly, and manual dexterity to work with small plastic and metal components in a high volume manufacturing setting.
  • Knowledge of lean, six sigma, kaizen, and continuous improvement initiatives a plus.
  • Ability to read, write, and speak English.
  • Ability to utilize basic math skills.
  • Execute tasks in a timely manner under general supervision.
  • Computer literacy required, Working knowledge of Microsoft Office Suite desired.
  • Meet all requirements outlined for Production Associate I INSERT PA1 Requirements.
  • 4 or more years of medical device manufacturing experience with relevant microscope experience or 2 or more years of intensive microscope job-related experience in a Class III medical device company.


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