Depot Repair Technician II

Job Summary

The Depot Repair Technician II (DRT II) is a mid-level technical role within Service & Repair Operations responsible for intermediate troubleshooting, inbound complaint investigation, system-level repair, and final Quality Control (QC) certification of returned medical devices in a centralized repair facility. Operating under general supervision with a high degree of operational autonomy, the DRT II performs complex failure analysis, evaluates active customer complaints, serves as an authorized signatory for final inspection and product release to customers, and provides technical guidance and mentoring to Depot Repair Technician I (DRT I) personnel.

This position operates in a highly regulated environment; all duties must adhere to FDA 21 CFR Part 820 Quality System Regulations and ISO 13485 standards, and quality-specific activities are subject to MPE and OEM Quality oversight.

Essential Duties and Responsibilities

Conduct intake inspections, visual triage, and diagnostic testing on clinical devices returned with active customer complaints; isolate, document, and cross-reference reported failures against complaint codes in the Quality Management System (QMS) Troubleshoot complex mechanical, electrical, and electronic assemblies down to the root component or circuit-board interface level Disassemble, repair, upgrade, and recalibrate electromechanical subsystems, software modules, and fluidic systems beyond basic Field Replaceable Units (FRUs) Perform post-repair verification testing, including electrical safety testing (e.

g., leakage current per IEC 60601-1 parameters) and device-specific operational calibrations Serve as an authorized technical signatory to independently perform quality control inspections and complete the documentation required for product release to the end user Generate accurate Device History Records (DHR), complaint investigation summaries, and non-conformance reports (NCR) in compliance with FDA 21 CFR Part 820 and ISO 13485; ensure full traceability of parts, calibrated tooling, and procedural workflows Ensure customer-returned clinical devices undergo validated sanitization and biological decontamination protocols; maintain chemical tracking logs Track shop tools, maintain sub-assembly stock thresholds, and participate in scheduled and unscheduled inventory audits and cycle counts Maintain a clean, organized bench workspace in accordance with Electrostatic Discharge (ESD) protection guidelines and 5S standards Education High school diploma or equivalent required Associate degree in Biomedical Equipment Technology (BMET), Electronic Engineering Technology, or equivalent military technical training/certification strongly preferred Experience and Knowledge 2 to 4 years of hands-on bench-level component troubleshooting, diagnostic device repair, or electrical testing experience Prior experience in an FDA-regulated manufacturing depot, medical field operations, or ISO 13485 cleanroom environment required Demonstrated ability to achieve and maintain internal MPE and original equipment manufacturer (OEM) technical certifications Thorough understanding of Good Documentation Practices (GDP) and quality-controlled repair processes Advanced ability to interpret OEM technical service manuals, schematics, piping and instrumentation diagrams (P&ID), micro-circuit layouts, and guided diagnostic flowcharts Proficiency with digital oscilloscopes, patient simulators, pressure/vacuum gauges, automated electrical safety analyzers, multimeters, and precision torque tools Physical and Mental Demands Ability to remain seated or standing at a repair bench for extended periods (up to 8 hours per shift) while maintaining focus and concentration Excellent hand-eye coordination and manual dexterity to handle micro-scale electronic components, solder dense circuit interfaces, route internal wiring harnesses, and seat delicate optical or fluidic sensor arrays Ability to independently lift, move, or position equipment weighing up to 40 lbs.

from shipping enclosures, transport skids, or repair work-stands Strong analytical thinking and problem-solving skills to isolate complex device failures High attention to detail and precision in testing, inspection, and documentation Ability to provide technical guidance and coaching to less experienced technicians Work Environment Centralized depot repair facility with ESD-controlled bench workstations Regular handling of customer-returned clinical devices that may present biohazard exposure prior to decontamination Required personal protective equipment (PPE) includes static-dissipative (ESD) smocks, safety glasses, anti-static wrist/heel grounding straps, and protective biohazard gloves during decontamination; PPE is adjusted to assigned work