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Prototype Assembler

2 months ago

San Clemente, United States ICU Medical Full time

Job Title 
Senior Electronics Repair Technician

FLSA Status
Non Exempt
 
Position Summary
This position will need to fully understand and demonstrate expertise when performing all activities necessary for Infusion Pump Service operations, including repair, rework refurbishment, out of box failures analysis, yield improvement and complaint investigations. In addition, this position will be responsible for training new employees on all aspects of the Service process, including PCI (Product Complaint Investigation) analysis, device history investigation, and true root cause analysis to component level if required.
 
Also responsible for documenting the required aspects of Infusion Pump PCI, repair, refurbishment, rework, and labor and material tracking jobs. This person must be an expert on the device tracking system (Oracle) so that the complaints are addressed, and all results are technically accurate and include required elements ensuring that the analysis/repair activity is properly recorded. 
 
Essential Duties & Responsibilities 
• Provide leadership for a product line repair, rework or refurbishment team. Coordinate and prioritize team activities working with Management and QA functions.
• Troubleshoot and analyze customer device returns to problem solve root cause issues.
• Comply with all the requirements in the Quality and Operational procedures in their area of responsibility to meet the requirements of all applicable Quality System Regulations (i.e. cGMP compliance) and ICU’s QMS
• Perform Level 2 and Level 3 PCI investigations, working with Engineering, QA, Customer Service and Global Complaint Management teams as necessary.
• Perform/assist with notebook/engineering studies, out of box failures analysis and yield improvement activity. 
• May perform troubleshooting and repair of devices onsite at customer locations as required. 
• Work with Manager or Supervisor and QA to identify and resolve process and/or product non-conformities. 
• Coordinate and perform On-the-Job training activities for repair and complaint investigation processes.
• Clean the assigned work area on daily basis to maintain clean work environment. 
• Work on special projects as they arise.
 
Knowledge, Skills & Qualifications 
• Demonstrate a high level of leadership, initiative, and teamwork skills
• Strong cGMP, process and product knowledge 
• Excellent verbal and written communication skills
• Ability to write and edit written process documentation
• Proven analytical thinking and problem-solving skills 
• Quality and results oriented 
 
Education and Experience
• High School diploma or GED equivalent
• Associate degree in a technical discipline from an accredited college or university is preferred or equivalent experience 
• Minimum 7-10 years industry experience in a high-tech manufacturing or servicing environment 
 
Minimum Qualifications 
• Must be at least 18 years of age 
• Must pass pre-employment drug screen and background check 
 
Travel Requirements
• Typically requires travel less than 25% of the time 
 
Physical Requirements and Work Environment
• Job duties are performed in a service repair hub environment 
• Must have high level of hand-eye coordination and manual dexterity to work with electro-mechanical medical devices 
• Must be able to move and lift objects of up to 25 lbs.