Machinist I

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.

• →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.

• High school diploma or equivalent required.
• Technical training in machining or manufacturing technology preferred.

• One to three years of machinist experience required, preferably within a medical device or regulated manufacturing environment.
• Experience operating CNC machining equipment preferred.
• Exposure to ISO 13485 and FDA Quality System Regulations (21 CFR Part 820) preferred.

• 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.
• Basic computer skills preferred.
• Effective verbal and written communication skills.

• Consistently produces work that meets specifications, quality standards, and customer requirements.
• Demonstrates attention to detail and follows inspection plans and procedures.

• Adheres to safety policies, quality procedures, and regulatory requirements.
• Maintains awareness of risks and takes appropriate action to prevent errors and nonconformances.

• Identifies issues, evaluates information, and implements appropriate corrective actions within scope of responsibility.
• Escalates concerns promptly when needed.

• Takes ownership of work quality, productivity, and attendance.
• Follows through on assignments with minimal supervision.

• Responds effectively to changing priorities, production demands, and business needs.
• Maintains performance during periods of change or unexpected events.

• Prioritizes tasks effectively to meet production schedules and customer commitments.
• Maintains accurate documentation and organized work practices.

• Works collaboratively with Production, Quality, Engineering, and other departments.
• Communicates clearly and professionally with team members and supervisors.

• Supports process improvement initiatives and contributes ideas to improve quality, efficiency, and workplace safety.
• Demonstrates a willingness to learn new skills and processes.