Operator IV

Resonetics; Fridley (MN); On-site; USD 33,000 - 43,000; Full time

Job summary

Resonetics is seeking an Operator IV in Fridley, MN to perform complex NPI build and assembly operations and provide technical support for R&D programs. You will test products and participate in product development activities in a fast-paced environment.

The role requires strong documentation skills, GMP knowledge, and the ability to work independently while collaborating with cross-functional teams. Overtime may be required to meet project timelines.

Qualifications

• High school diploma or GED required.
• 10+ years of assembly/manufacturing experience with increasing complexity.
• Ability to read measurement equipment (caliper, micrometer, microscope).
• Knowledge of GMP and clean room environments.

Responsibilities

• Work with project team to meet customer demand and production schedules.
• Read work orders and follow drawings and sample assemblies; complete SWOs/work orders.
• Document Lab Notebooks, DMRs, LHRs, inspection and validation documents.
• Provide training and cross-training to team members as needed.
• Maintain equipment, calibrate on schedule, and ensure clean, safe work area.

Skills

Independent worker

Critical thinking

Attention to detail

Reading blueprints/drawings

Education

High school diploma or GED

Tools

Caliper

Micrometer

Ruler

Microscope

Job description

Overview

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

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.

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 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

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

Compensation

• The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $24.00–$31.00/hr.
• Our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.