Maintenance Equipment Technician

Angel Aligner; Oak Creek (WI); Vor Ort; USD 40.000 - 65.000; Vollzeit

Benefits dieser Stelle

Competitive base salary

Benefits

Zusammenfassung

Valid8 Financial, Inc. Oak Creek, WI is seeking an Equipment Technician to install, maintain, troubleshoot, and repair production equipment for a medical device manufacturing operation.

You will ensure uptime, calibration, and documentation in line with FDA 21 CFR Part 820 and ISO 13485, supporting engineering with improvements and process validations. The role requires strong mechanical and electrical troubleshooting, the ability to read schematics, and familiarity with regulated quality

Qualifikationen

• High school diploma or equivalent required.
• 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.
• Experience with PLCs and electrical control principles in manufacturing or medical devices is preferred.
• Proficient in using testing tools such as multimeters, oscilloscopes and megohmmeters.

Aufgaben

• Perform preventive and corrective maintenance on production equipment and tooling.
• Troubleshoot mechanical, electrical, pneumatic, and control system issues to minimize downtime.
• Install new equipment and assist with IQ/OQ/PQ
• Maintain maintenance logs, calibration records, and equipment history files.
• Ensure compliance with FDA/ISO13485 and internal quality systems.
• Respond quickly to equipment issues to support manufacturing teams.
• Coordinate with external calibration vendors as needed.
• Support engineering with equipment improvements and process validations.
• Monitor spare parts inventory and request replenishment.
• Follow lockout/tagout and safety procedures; handle tools/chemicals properly.
• Participate in root cause investigations, CAPA, and nonconformances.
• Provide equipment documentation to support audits.

Kenntnisse

Preventive maintenance

Troubleshooting

Mechanical aptitude

Electrical knowledge

Reading schematics

Quality systems compliance

PLC programming (Siemens/Mitsubishi)

Calibration tools

Documentation

Independent work

Ausbildung

High school diploma or equivalent

Technical certificate or associate degree preferred

Tools

Siemens PLC programming

Mitsubishi PLC programming

Electrical control principles

Calibration instruments (multimeters/oscilloscopes/megohmmeters)

Jobbeschreibung

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.
• 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

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.
• 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.