Job Description

Job Description:

We are seeking a Biomedical Device Technician who will be responsible for performing diagnostic, repair, and refurbishment activities on infusion pumps and related medical devices. This individual will also support Product Complaint Investigations (PCI), analyze out-of-box failures, and conduct root cause investigations down to the component level. In addition, the role may involve mentoring junior technicians and training new employees on service procedures and documentation protocols.

Key Responsibilities:

• Conduct repairs, reworks, upgrades, and refurbishments on a variety of infusion pump models, adhering to established service guidelines.
• Analyze and troubleshoot customer device returns to determine root cause and recommend corrective actions.
• Perform Level 0 and Level 1 Product Complaint Investigations (PCI), including data gathering and technical documentation.
• Participate in complaint investigations and determine root cause down to component level when required.
• Collaborate with QA, engineering, and complaint handling teams for comprehensive failure analysis and product improvement.
• Accurately document service activities, including repair actions, materials used, and labor hours, in tracking systems (e.g., Oracle).
• Train and support new hires and junior technicians in service processes, PCI analysis, and quality standards.
• Assist with engineering studies, out-of-box failure evaluations, and continuous improvement efforts.
• Maintain a clean and organized work environment in compliance with cGMP and company standards.
• Occasionally perform field service or support customer visits if needed.
• Contribute to quality system improvements by identifying recurring issues and suggesting process enhancements.

Required Qualifications:

• High School Diploma or GED required; Associate’s Degree in electronics, biomedical engineering, or a related technical field preferred.
• 1–3 years of hands-on experience in a regulated service repair, manufacturing, or medical device environment.
• Strong understanding of quality systems, particularly FDA QSR/cGMP regulations.
• Proficient in using electronic tracking systems such as Oracle or equivalent ERP platforms.
• Demonstrated ability to perform root cause analysis and component-level troubleshooting.

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