Biomedical Depot Repair Technician II - QC & Troubleshooting

Mpe Inc; Milwaukee (WI); Sur place; USD 72 000 - 83 000; Plein temps

Résumé du poste

The Depot Repair Technician II (DRT II) at Mpe Inc in Milwaukee, WI, performs intermediate troubleshooting, inbound complaint investigation, repair, and final QC certification of returned medical devices in a centralized repair facility.

Under general supervision, you will conduct complex failure analysis, sign off on product release, and maintain DHR/NCR documentation while following FDA 21 CFR Part 820 and ISO 13485 standards, mentoring DRT I personnel.

Qualifications

• 2 to 4 years bench-level troubleshooting or repair experience.
• FDA-regulated manufacturing depot, medical field operations, or ISO 13485 exposure.
• Good Documentation Practices and GDP in repair processes.

Responsabilités

• Perform intake inspections, diagnostic testing, and document failures in QMS.
• Troubleshoot mechanical, electrical, and electronic assemblies to root causes.
• Disassemble, repair, recalibrate subsystems and software modules.
• Post-repair verification testing and IEC 60601-1 safety checks.
• Sign as authorized technical inspector for final product release to customers.
• Generate DHR, NCR, and ensure traceability of parts and tooling.
• Maintain clean, ESD-protected bench and follow 5S standards.

Connaissances

Troubleshooting

Root cause analysis

Documentation

Electrical testing

Formation

High school diploma

BMET / Electronic Engineering Tech degree

Outils

Oscilloscopes

Multimeters

Electrical safety testers

Torque tools

Description du poste

The Depot Repair Technician II (DRT II) at Mpe Inc in Milwaukee, WI, performs intermediate troubleshooting, inbound complaint investigation, repair, and final QC certification of returned medical devices in a centralized repair facility.

Under general supervision, you will conduct complex failure analysis, sign off on product release, and maintain DHR/NCR documentation while following FDA 21 CFR Part 820 and ISO 13485 standards, mentoring DRT I personnel.