Job Description

Position Summary:

We are seeking a skilled Medical Device Repair/Service Technician to join our Product Complaint Investigation (PCI) team. In this role, you will perform root cause analysis, device history reviews, and hands-on repair, refurbishment, and upgrade of electro-mechanical medical devices. You will work on both routine and complex technical issues with a focus on quality, compliance, and patient safety.

Key Responsibilities:

• Conduct detailed Product Complaint Investigations (PCI) on returned medical devices to determine root cause of failure.
• Perform device history record reviews to support investigation findings and regulatory reporting.
• Carry out repairs, reworks, refurbishments, and upgrades of returned or in-field devices following established SOPs and work instructions.
• Utilize strong manual dexterity and hand-eye coordination to work with small components in electro-mechanical assemblies.
• Document all work clearly and accurately in accordance with cGMP and ISO 13485 requirements.

Qualifications:

• High school diploma; Associate Degree or technical certification in electronics, biomedical engineering, or a related field is a plus.
• 1–3 years of experience in medical device repair in regulated manufacturing/service environment.
• Strong knowledge of electro-mechanical systems.
• Familiarity with Product Complaint Investigations and regulatory requirements such as FDA QSR, ISO 13485, and cGMP.
• Excellent documentation practices and attention to detail.
• Ability to work independently and as part of a team in a fast-paced environment.
• Experience in a medical device company or similar highly regulated industry.
• Proficiency with ERP systems and quality management software.

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