Machinist I
About The Position
The Machinist is responsible for operating precision CNC machining equipment to manufacture medical device components that meet established quality, safety, and production requirements. This role performs machine operation, inspections, tooling changes, machine adjustments, preventive maintenance, and documentation activities while ensuring compliance with company procedures, customer specifications, and applicable medical device regulations. The Machinist plays a critical role in maintaining product quality, production efficiency, and a safe, organized work environment.
Requirements
- High school diploma or equivalent required.
- One to three years of machinist experience required, preferably within a medical device or regulated manufacturing environment.
- Ability to read and interpret blueprints, engineering drawings, and specifications.
- Proficiency using precision measuring instruments, including: Calipers, ID/OD Micrometers, Depth Gauges, Indicators, Plug Gauges, Thread Go/No-Go Gauges.
- Understanding of inspection methods, testing equipment, and quality control practices.
- Knowledge of basic machining processes, tooling, and machine adjustments.
- Strong mathematical skills, including addition, subtraction, multiplication, division, geometry, and basic algebra.
- Ability to accurately complete production and quality documentation.
- Effective verbal and written communication skills.
Nice To Haves
- Technical training in machining or manufacturing technology preferred.
- Experience operating CNC machining equipment preferred.
- Exposure to ISO 13485 and FDA Quality System Regulations (21 CFR Part 820) preferred.
- Basic computer skills preferred.
Responsibilities
- Operate assigned precision CNC machining equipment in accordance with approved work instructions, process documentation, and safety procedures.
- Review process travelers and verify revision levels match current production requirements.
- Confirm previous operations have been completed and documented appropriately before beginning work.
- Load raw materials, pallets, and robotic systems as required.
- Verify machine programs and revision levels match traveler requirements before production begins.
- Perform in-process inspections and final checks using precision measuring equipment and inspection plans.
- Read and interpret blueprints, engineering drawings, specifications, and work instructions.
- Make machine offsets and minor adjustments as necessary to maintain part conformance to specifications.
- Replace tooling and perform routine machine setup adjustments as required.
- Identify and segregate nonconforming products by following established out-of-specification (OOS) procedures and notifying Quality personnel.
- Follow line clearance procedures to ensure product integrity and prevent mix-ups.
- Maintain acceptable production output while meeting quality standards and manufacturing schedules.
- Perform and document routine preventive maintenance activities on assigned equipment.
- Maintain a clean, organized, and safe work area, including machines, tooling, and materials.
- Participate in required meetings, training sessions, and continuous improvement activities.
- Adhere to all company policies, safety requirements, quality standards, and regulatory requirements.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
