Operator IV

Resonetics•Fridley, MN

4d•Onsite

About The Position

The Operator IV role will be responsible for conducting complex NPI build/assembly operations, technical support for R&D programs, testing of product, and product development activities. Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Requirements

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 ausing 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

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.