Position Summary
This position will need to understand and demonstrate the ability to perform activities necessary for Infusion Pump Service operations, including repair, refurbishment, out of box failures analysis and complaint investigations. In addition, this position may be responsible for training new employees on key 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 proficient with 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
Will perform routine and complex work related to the repair, rework, refurbishment or upgrades of medical devices.
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).
Perform Level 0 and Level 1 PCI investigations on a regular basis, working as necessary with Senior Technicians, QA, Customer Service and Global Complaint Management teams as necessary.
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.
Work with Manager and QA to identify and resolve process and/or product non-conformities.
Assist Senior Technicians or Engineering with On-the-Job training activities as required.
Clean the assigned work area on daily basis to maintain clean work environment.
Work on special projects as they arise.
Knowledge, Skills & Qualifications
Demonstrate initiative and good teamwork skills
Proficient with cGMP, process, and product knowledge
Good verbal and written communication skills
Ability to edit written process documentation as necessary
Proven analytical thinking and problem-solving skills
Quality and results oriented
Education and Experience
High School diploma or GED equivalent
A.S. degree in a technical discipline preferred, or equivalent experience
Minimum of 5 years of industry experience in a high-tech manufacturing, service repair or related environment
Minimum Qualifications
Must be at least 18 years of age
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 lift 30-40 lbs.