Operator IV

Responsibilities

• 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, receive verbal instructions regarding duties to be performed, and complete necessary SWO's or work orders as required
• Report problems or concerns with quality, processes, engineering, equipment, materials, or labor the supporting engineer, project team, lead, or supervisor
• Accurately complete all essential documents (i.e., Lab Notebooks, Device Master 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.

Required Qualifications

• High school graduate or GED equivalent
• 10+ years of assembly and/or manufacturing experience with increasing complexity
• Demonstrated ability to read and understand measurement equipment (e.g., caliper, ruler, micrometer, microscope)
• Working knowledge of Good Manufacturing Practices (GMP)
• Ability to work independently with little oversight and apply critical reasoning skills
• 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 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 Demands

• 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