Medical Device Manufacturing Specialist

3 weeks ago

Houston, Texas, United States DJO Global Full time

Job Summary:

We are seeking a highly skilled Medical Device Manufacturing Specialist to join our team at DJO Global. As a key member of our manufacturing team, you will be responsible for assembling and packaging medical device products to high quality standards in a cleanroom environment.

Key Responsibilities:

  • Assemble plastic and metal components into medical devices in accordance with approved manufacturing procedures in a cleanroom environment.
  • Follow all relevant procedures for the production environment.
  • Using Work Order, gather all needed materials and document inventory usage.
  • Meticulously follow work instructions and complete Device History Records for completed devices and work in progress, ensuring that all appropriate procedures and work instructions are followed and may be involved in inventory control.
  • Perform visual inspections and functional tests to ensure that devices meet quality standards and regulatory requirements.
  • Maintain lot number traceability throughout the manufacturing process.
  • Perform in-process quality checks on subassemblies and finished products.
  • Maintain accurate records of assembly processes, test results, and any deviations encountered during manufacturing.
  • Practice and promote safety, quality, and efficiency within the team.
  • Identify opportunities for process optimization and efficiency improvements.
  • Participate in continuous improvement activities, including daily management, GEMBA walks, Kaizen events, etc.
  • Maintain accurate records of clean room activities, including maintenance logs, incident reports, and procedural updates.
  • Maintain a controlled environment and assembly area in clean order.
  • Perform equipment and cleanroom maintenance as required.

Requirements:

  • HS Diploma or equivalent.
  • Prior cleanroom and/or medical device assembly/production experience.
  • Ability to read drawings/blueprints.
  • Familiarity with basic hand tools, e.g., caliper, micrometer, height gage, etc.

Preferred Qualifications:

  • Execute tasks in a timely manner under general supervision.
  • Demonstrated attention to detail and ability to follow defined processes and procedures.
  • High aptitude to learn.

Work Environment and Physical Demands:

  • Climate-controlled workspace.
  • Ability to sit or stand for extended periods of time.
  • Frequent to constant use of hands and fingers to handle or feel and to manipulate in a variety of different body positions or postures.
  • Frequent to constant holding, grabbing, grasping, pinching, turning, or otherwise working with hands and fingers ranging from dexterous to forceful in nature.
  • Ability to tug, pull, or lift up to 50 lbs.
  • Periodic weekend or evening work.

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