Hybrid Medical Device Complaints & Failure Analysis Eng

3 Key Consulting, Inc.; Thousand Oaks (CA); Hybrid; USD 58,000 - 65,000; Part time

Job summary

3 Key Consulting, Inc. in Thousand Oaks, CA is hiring a Medical Device Complaint & Failure Analysis Engineer for a contract engagement with our direct client, a leading global biopharmaceutical company.

The role focuses on evaluating complaints and performing failure analysis on class II/III devices, with hands-on lab work and formal reporting. The ideal candidate has a engineering/science background, ISO systems experience, and strong communication skills for cross-functional presentations.

Qualifications

• 5 years of experience in complaints handling and failure analysis investigations within a medical device environment (class II/III).
• Bachelor's degree in engineering or sciences; robust lab experience. Master’s preferred.
• Experience with ISO systems, risk analysis, and report writing.

Responsibilities

• Lead evaluation of returned products and document results.
• Prepare assessment reports on time per client requirements.
• Support investigations with testing, data analysis, and root cause analysis.
• Maintain and update lab equipment procedures and SOPs.
• Present findings to internal teams and management.

Skills

Complaint handling

Failure analysis

Medical devices

Written communication

Education

Bachelor's degree in engineering or sciences

Master's degree preferred

Tools

CT Scanner

Instron testing machines

Job description

3 Key Consulting, Inc. in Thousand Oaks, CA is hiring a Medical Device Complaint & Failure Analysis Engineer for a contract engagement with our direct client, a leading global biopharmaceutical company.

The role focuses on evaluating complaints and performing failure analysis on class II/III devices, with hands-on lab work and formal reporting. The ideal candidate has a engineering/science background, ISO systems experience, and strong communication skills for cross-functional presentations.