Technical Operator I, Instrument Service - San Diego

Overview

Position Summary:

The Technical Operator I performs routine mechanical, electromechanical, and electronic technical activities related to the service of returned instruments. The operator will also maintain a high level of attention to detail during troubleshooting, repair, and documentation of the latter on Device History Records and/or checklists. Day to day, the team member will work in a collaborative setting with other engineers and cross-functional partners while maintaining a sense of urgency and accuracy to ensure customer satisfaction.

Responsibilities

 

Minimum Knowledge & Experience Required for the Position:

• Troubleshoot and repair field returned instruments, loaners, and printed circuit boards (PCB) to the component level and subassemblies and is responsible for complying with all appropriate regulatory bodies (FDA, ISO, e.g.) mandated policies, procedures, work instructions, and records.
• Ability to follow Engineering Change Orders (ECO), Standard Operating Procedures (SOPs), technical documents, reports, and manuals.
• Perform decontamination of returned instruments for repair.
• Maintain device history records and service reports associated with instrument repairs.
• Enter data into Enterprise Resource Planning (ERP) system.
• Accurately transact parts and inventory used in repair of returned instruments.
• Maintain a clean, organized, and safe work environment in the service center.
• Continually work to achieve assigned goals; meet unscheduled peaks in workload as necessary to ensure no delay for customers.
• Other duties as assigned by leadership.

Qualifications

 

Minimum Knowledge & Experience Required for the Position:

• High school diploma or equivalent.
• At least two (2) years previous instrument repair or equivalent experience; previous experience in a regulated medical device manufacturing or pharmaceutical environment strongly preferred.

  

Skills & Capabilities:

• Competent with various types of measurement equipment, digital multi-meter, oscilloscope, and AC/DC power supplies.
• Knowledge of basic electronics for component functionality preferred.
• Ability to solder small components.
• Competent utilizing various test fixtures, assembly jigs, and tools.
• Ability to utilize assembly drawing and schematics.
• Familiarity with maintaining inventory of instruments and spare parts.
• Familiarity with GDP and GMP
• Ability to effectively communicate with peers and management through all methods.
• Ability to collaborate with immediate team members.