Hybrid Medical Device Failure and Complaint Investigator

3key Consulting, Inc.; Thousand Oaks (CA); Hybrid; USD 56,000 - 63,000; Full time

Job summary

3 Key Consulting is seeking a Medical Device Complaint & Failure Analysis Engineer for a 1+ year contract in Thousand Oaks, CA. Local candidates only with hybrid onsite 3 days per week.

The ideal candidate has 5+ years in complaints handling and failure analysis for Class II/III devices, proficiency with ISO systems and risk analysis, and strong written and verbal communication skills for regular presentations to internal teams.

Qualifications

• 5 years of complaints handling and failure analysis in a medical device environment (class II/III).
• Strong written and verbal communication skills for regular presentations.
• Proficiency with ISO systems and risk analysis processes.

Responsibilities

• Lead evaluation of returned products and document results in a report.
• Support lab infrastructure and equipment, including training personnel.
• Perform root cause analyses for mechanical/electromechanical products.

Skills

Complaint handling

Failure analysis

Communication skills

Education

Bachelor's degree in engineering or sciences

Master's degree in Science

Tools

CT scanner

Instron testing

Job description

3 Key Consulting is seeking a Medical Device Complaint & Failure Analysis Engineer for a 1+ year contract in Thousand Oaks, CA. Local candidates only with hybrid onsite 3 days per week.

The ideal candidate has 5+ years in complaints handling and failure analysis for Class II/III devices, proficiency with ISO systems and risk analysis, and strong written and verbal communication skills for regular presentations to internal teams.