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:
- 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.
Qualifications:
- 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.
Preferred but not required Qualifications:
- 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.
Competencies:
- Mechanical and electrical aptitude
- Strong problem‑solving and root-cause analysis
- Strong communication and teamwork
- Commitment to safety and product quality
- Continuous improvement mindset
- Ability to prioritize and manage multiple tasks
Physical and Work Environment Requirements:
- 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.
Travel & Benefits
- Minimal travel up to 5% required; may include international overnight stays.
- Standard shift with occasional on‑call or weekend support.
- We offer a competitive base salary and benefits.