Biomedical / Electrical / Mechanical Engineer – Medical Device Quality

Motion Recruitment; Irvine (CA); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Health Insurance

401k

Job summary

Motion Recruitment is seeking a Biomedical/Regulatory Quality Engineer to investigate technical customer complaints and manufacturing nonconformities for medical devices through hands-on troubleshooting. The engineer will document findings, monitor complaint trends, and collaborate with cross-functional teams to implement corrective actions and process improvements.

A Bachelor's degree in Biomedical, Electrical, or Mechanical Engineering is strongly preferred, with at least one year of

Qualifications

• Bachelor's degree in Biomedical, Electrical, or Mechanical Engineering with at least 1 year of professional experience.
• Experience in regulated manufacturing with FDA regulations and ISO 13485 strongly preferred.
• Experience in medical device quality, CAPA, and complaint handling is desirable.

Responsibilities

• Investigate technical customer complaints and manufacturing nonconformities.
• Document findings and monitor complaint trends.
• Collaborate with cross-functional teams to implement corrective actions.
• Drive process improvements and CAPA effectiveness.

Skills

Technical Troubleshooting

Product Evaluation

Root Cause Analysis

Quality Investigations

Complaint Handling

Medical Device Quality

CAPA

Post-market Surveillance

Analytical Skills

Cross-functional Collaboration

Education

Bachelor's degree in Biomedical, Electrical, or Mechanical Engineering

Tools

SAP

Microsoft Excel

ISO 13485

FDA Regulations

Job description

The role involves investigating technical customer complaints and manufacturing nonconformities for medical devices through hands-on troubleshooting. The engineer will document findings, monitor complaint trends, and collaborate with cross-functional teams to implement corrective actions and process improvements.

Requirements: A Bachelor's degree in Biomedical, Electrical, or Mechanical Engineering is strongly preferred, along with at least one year of professional engineering experience. Experience in regulated manufacturing, specifically with FDA regulations and ISO 13485, is highly desired.

Key Skills: Technical Troubleshooting, Product Evaluation, Root Cause Analysis, Quality Investigations, Complaint Handling, Medical Device Quality, SAP, Technical Documentation, ISO 13485, FDA Regulations, CAPA, Post-market Surveillance, Microsoft Excel, Analytical Skills, Cross-functional Collaboration

Benefits: Health Insurance, 401k