Maintenance Equipment Technician
We’re a New State of the Art Technology Manufacturing Plant in Oak Creek, WI!
Job Summary: The 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.
Essential Functions:
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Performs preventive and corrective maintenance on production equipment, tooling, and automated systems.
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Troubleshoots mechanical, electrical, pneumatic, and control system issues to minimize downtime.
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Installs new equipment and assists with equipment qualifications (IQ/OQ/PQ).
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Maintains accurate maintenance logs, calibration records, and equipment history files.
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Ensures all work complies with FDA, ISO 13485, and internal quality system requirements.
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Supports manufacturing teams by responding to equipment issues quickly and effectively.
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Performs equipment calibrations and coordinates with external calibration vendors when needed.
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Assists engineering with equipment improvements, process validations, and continuous improvement projects.
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Monitors spare parts inventory and requests replenishment as needed.
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Follows lockout/tagout, safety procedures, and proper handling of tools and chemicals.
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Participates in root cause investigations, CAPA activities, and equipment‑related nonconformances.
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Supports audits by providing equipment documentation and maintenance records.
Qualifications:
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High school diploma or equivalent required; technical certificate or associate degree preferred.
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1+ year of experience in operation and maintenance of automated production line equipment.
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Strong mechanical and electrical troubleshooting skills.
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Ability to read schematics, technical drawings, and equipment manuals.
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Familiarity with FDA 21 CFR Part 820, ISO 13485, or other regulated quality systems.
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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.
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Proficient in using testing tools such as multimeters, oscilloscopes and megohmmeters; master mechanical disassembly, assembly and hydraulic/pneumatic maintenance skills.
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Hold an Electrician Special Operation Certificate; candidates with Welder Certificate or Pressure Vessel Special Equipment Operation Certificate are preferred.
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Ability to work independently and in a fast‑paced production environment.
Preferred but not required Qualifications:
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Experience in the medical device, pharmaceutical, or other regulated industry.
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Hands‑on experience with calibration systems, metrology, or test equipment.
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Familiarity with cleanroom environments and sterile device manufacturing.
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Continuous Improvement experience with structured problem‑solving methodologies.
Competencies:
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Mechanical and electrical aptitude
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Strong problem‑solving and root-cause analysis
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Strong communication and teamwork
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Commitment to safety and product quality
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Continuous improvement mindset
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Ability to prioritize and manage multiple tasks
Physical and Work Environment Requirements:
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Ability to stand, walk, bend, and lift up to 50 lbs.
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Work performed in manufacturing, cleanroom, and equipment areas.
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Use of PPE as required (safety glasses, gloves, etc.).
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Ability to work occasional overtime or off‑shift hours for urgent repairs.
Travel & Benefits
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Minimal travel up to 5% required; may include international overnight stays.
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Standard shift with occasional on‑call or weekend support.
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We offer a competitive base salary and benefits.
