CNC Machinist
Location: Monticello, MN
Employment Type: Full-Time
Summary
The CNC Machinist is responsible for setting up, operating, and producing precision components within a regulated machining environment. This role requires adherence to ISO 13485 standards, strong technical capability with multi-axis CNC equipment, and the ability to perform detailed visual and dimensional inspections.
Essential Functions
- Set up and operate Citizen, Tsugami, and Index multi-spindle lathes, as well as 3-4-5 axis CNC equipment including RoboDrills, Mill Turn machines, and horizontal/vertical mills.
- Perform tool changes, offsets, and adjustments to maintain efficient production.
- Set up complex components for both legacy and new production orders.
- Conduct inspections using microscopes, micrometers, calipers, pin/thread gauges, comparators, Micro-Hite, CMM, and vision systems.
- Perform routine preventive maintenance on CNC equipment.
- Support troubleshooting for complex machine or process issues.
- Complete required quality and inspection documentation.
- Maintain proper material control, identification, and traceability.
- Train and mentor junior machinists; support continuous improvement initiatives.
- Use ERP and QMS systems for documentation and traceability.
- Conduct Gauge R&R activities and AQL inspections; complete Qualification and First Article inspections.
- Make basic adjustments on FANUC (or similar) robot programs.
- Follow all safety requirements, PPE guidelines, and quality system procedures.
- Perform additional duties as needed.
Qualifications
- Experience in regulated medical device manufacturing (Class I, II, or III).
- Knowledge of GMP/ISO standards, including ISO 13485.
- Strong mechanical aptitude and experience with CNC setup, troubleshooting, and inspection.
- Ability to read blueprints, specifications, and procedures.
- Proficiency with hand tools and basic machine maintenance.
- Strong attention to detail and ability to identify nonconformances.
- Proficient in Microsoft Excel and Word.
- Strong verbal and written communication skills.
- Ability to work independently and in cross-functional teams.
Education
- Machine Trades Technical School certification or equivalent experience in manufacturing or engineering.
Experience
- Technical certification and3+ years of CNC machining experience in a regulated medical environment
OR
- 5+ years of CNC machining experience in a regulated medical environment.
Physical Requirements
- Ability to bend, stoop, squat, kneel, and lift up to 50 lbs.
- Ability to perform repetitive hand/arm movements and handle small components.
- 20/20 vision (corrected or uncorrected) and good manual dexterity.
- Exposure to oils, greases, noise, solvents, dust, coolant, and sharp materials; PPE required.
- Ability to sit or stand for extended periods.
You should be proficient in:
- GD&T
- Equipment Troubleshooting
- CNC Tooling
- Troubleshooting Skills
- CNC Programming
- CNC Machine Repair
- CNC Machine Installation
- G-Code
- Tape Measure Reading
- M-Code
- CNC Machine Setup & Changeover
- Precision Measurement & Hand Metrology
- Machine Geometry & Alignment
- Machine Setups for Production Runs
Machines & technologies you'll use:
- CNC Lathe (2-4 axis) (Mazak, Haas, Okuma, Doosan)
- CNC Swiss Lathe (Star, Citizen, Tsugami, Index)
- CNC Lathe (5+ axis) (Mazak, Okuma, Doosan, Index)