Operator IV; Implantable

Job Summary

Job Summary The Operator IV role will be responsible for conducting complex builds of long term active implantable Class 3 devices, technical support for R&D programs, testing of product, and product development activities.

The Operator IV role will be responsible for conducting complex builds of long term active implantable Class 3 devices, technical support for R&D programs, testing of product, and product development activities.

• 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 to 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.

• High school graduate or GED equivalent
• 10+ years of medical device 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 performing small scale assembly work under a microscope in a clean room and ESD controlled environment
• Experience with circuit board soldering, laser and resistance weld assembly, and hermetic laser welding
• Experience with IPG header assemblies (epoxy potting and pre-molded bonding using medical adhesives and epoxies)
• Experience with neuromodulation lead assembly/processing (cable to electrode welding, molding, centerless grinding, RF bonding, and testing)
• 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

• 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

• Group health & welfare benefits:
  Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts.
• Company-paid benefits:
  Employee Life Insurance & Ad&D, Long Term Disability (LTD), Kavira (requires participation in medical plan).
• Voluntary, employee-paid benefits:
  Employee…