Operator III

3 weeks ago

Fridley, United States Resolution Medical Full time
Job Type

Full-time

Description

Job Summary

Operator III role will be responsible for conducting general manufacturing operations, technical support for R & D programs, testing of product, and product development activities.

Essential Functions
  • Work with project team, Line Lead, or Supervisor to ensure customer demand and the production schedules are met
  • Read work orders, follow production drawings and sample assemblies, receives verbal instructions regarding duties to be performed, and complete necessary SWO's or work orders as required
  • Report problems or concerns with quality, processes, equipment, materials, or labor the supporting engineer, project team, lead, or supervisor
  • Accurately complete all essential documents (i.e., Lab Notebooks, DeviceMaster Records (DMR's), Lot History Records (LHR's), Inspection Records and Validation Documentation
  • Provide training to new team members and provide cross-training for current team members
  • Record observations of both assembly processes and assembly (or component) performance
  • Identify opportunities for productivity and quality improvements
  • Ensure equipment is maintained and calibrated within defined timelines when possible in order to minimize interruption to production lines
  • Adjusts and trims materials from components to achieve specified medical or dimensional characteristics
  • Maintain a clean, safe, and organized work environment
  • Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements.

Requirements

Education, Experience, Required Skills
  • High school graduate or GED equivalent
  • 5+ years of assembly and/or manufacturing experience
  • Accurately read work orders, following production drawings, and receive instruction
  • Accurately complete all essential documents (Lab Notebooks, Device Master Records, Lot History Records, Inspection Records, and Validation Documentation)
  • Experience and/or training in using a microscope in assembly, working with different types of catheter materials, or other similar medical devices with small parts
  • Ability to handle and be trusted with confidential and/or sensitive information.
  • Able to work in a fast-paced, constantly changing environment.
  • Ability to be flexible and to handle multiple projects in an organized, timely manner.
  • Able to problem-solve, work under pressure, and to effectively manage stress.
  • Ability to work overtime as needed

Physical Requirements
  • Prolonged periods of sitting at a desk and working on a computer and/or microscope
  • Prolonged periods of standing and/or walking
  • Must be able to lift up to 25 pounds at times
  • Manual dexterity in order to assemble products or machines as directed
  • Excellent hand-eye coordination
  • Ability to differentiate between colored wires, tabs, and electronic components
  • Must wear gown, gloves, and ear protection when applicable
  • Must be willing to work in lab and clean room environments to support project work

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