Equipment Maintenance Technician

Job Summary

The Maintenance Equipment Technician supports a medical device manufacturing operation by installing, maintaining, troubleshooting, and repairing production equipment to ensure safe, reliable, and compliant performance. This role plays a key part in equipment uptime, preventive maintenance, calibration, and documentation required under FDA 21 CFR Part 820 and ISO 13485.

• Performs preventive and corrective maintenance on production equipment, tooling, and automated systems.
• Troubleshoots mechanical, electrical, pneumatic, and control system issues to minimize downtime.
• Installs new equipment and assists with equipment qualifications (IQ/OQ/PQ).
• Maintains accurate maintenance logs, calibration records, and equipment history files.
• Ensures all work complies with FDA, ISO 13485, and internal quality system requirements.
• Supports manufacturing teams by responding to equipment issues quickly and effectively.
• Performs equipment calibrations and coordinates with external calibration vendors when needed.
• Assists engineering with equipment improvements, process validations, and continuous improvement projects.
• Monitors spare parts inventory and requests replenishment as needed.
• Follows lockout/tagout, safety procedures, and proper handling of tools and chemicals.
• Participates in root cause investigations, CAPA activities, and equipment‑related nonconformances.
• Supports audits by providing equipment documentation and maintenance records.

• High school diploma or equivalent required; technical certificate or associate degree preferred.
• 1+ year of experience in operation and maintenance of automated production line equipment.
• Strong mechanical and electrical troubleshooting skills.
• Ability to read schematics, technical drawings, and equipment manuals.
• Familiarity with FDA 21 CFR Part 820, ISO 13485, or other regulated quality systems.
• Familiar with assembly line equipment, Siemens/Mitsubishi PLC programming and electrical control principles; those with experience in operating and maintaining non-standard automated equipment, especially in manufacturing or medical device industries are prioritized.
• Proficient in using testing tools such as multimeters, oscilloscopes and megohmmeters; master mechanical disassembly, assembly and hydraulic/pneumatic maintenance skills.
• Hold an Electrician Special Operation Certificate; candidates with Welder Certificate or Pressure Vessel Special Equipment Operation Certificate are preferred.
• Ability to work independently and in a fast‑paced production environment.

• Experience in the medical device, pharmaceutical, or other regulated industry.
• Hands‑on experience with calibration systems, metrology, or test equipment.
• Familiarity with cleanroom environments and sterile device manufacturing.
• Continuous Improvement experience with structured problem‑solving methodologies.
• Mechanical and electrical aptitude
• Strong problem‑solving and root-cause analysis
• Strong communication and teamwork
• Commitment to safety and product quality
• Ability to prioritize and manage multiple tasks

• Ability to stand, walk, bend, and lift up to 50 lbs.
• Work performed in manufacturing, cleanroom, and equipment areas.
• Use of PPE as required (safety glasses, gloves, etc.).
• Ability to work occasional overtime or off‑shift hours for urgent repairs.
• Minimal travel; may include overnight stays.
• Standard shift with occasional on‑call or weekend support.
• We offer a competitive base salary and benefits.