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.