Senior Plant Electrical Engineer
4 days ago
Job Summary
This position is responsible for learning, understanding, and following written processes necessary for Infusion Pump Service operations, including repair, rework, refurbishment, out of box failures analysis, and complaint investigations.
Key aspects of the Service process include PCI (Product Complaint Investigation) analysis and device history investigation.
The successful candidate will be responsible for documenting required aspects of Infusion Pump PCI, repair, refurbishment, rework, and labor and material tracking jobs.
This person must be able to operate the device tracking system (Oracle) to address complaints and ensure all results are technically accurate and include required elements.
Essential Duties & Responsibilities
- Perform routine and work related to the repair, rework, or refurbishment of medical devices.
- Troubleshoot and analyze customer device returns to problem solve root cause issues, working with Senior or Lead Technicians or the Supervisor or Manager as needed.
- Comply with all 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 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.
- Work with Manager and QA to identify and resolve process and/or product non-conformities.
- Clean the assigned work area on a daily basis to maintain a clean work environment.
- Work on special projects as they arise.
Knowledge, Skills & Qualifications
- Demonstrate initiative and good teamwork skills.
- Experience with cGMP, process, and product knowledge a plus.
- Verbal and written communication skills.
- Ability to read, understand, and follow complex written procedures.
- 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 2 years of 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 hand-eye coordination and manual dexterity to work with electro-mechanical medical devices.
- Must be able to lift 25 lbs.
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