Design Assurance Engineer - Medical Devices (CAPA & Risk)

IT Minds LLC; La Quinta (CA); On-site; USD 100,000 - 140,000; Full time

Job summary

IT Minds LLC seeks two experienced Design Assurance Engineers to back a high-visibility medical device quality initiative in Southern California. You will collaborate with Quality, Manufacturing, Supplier Quality, and Engineering to strengthen design controls, risk management, CAPA execution, sustaining engineering, and change assessment activities.

The role focuses on root cause analysis, CAPA closure, and ensuring DHF documentation and ECO reviews meet FDA and ISO 13485 standards.

Qualifications

• Experience with Design Controls, Design Assurance, and Risk Management in a regulated medical device environment.
• Hands-on CAPA leadership including root cause analysis and corrective actions.
• Knowledge of FDA, ISO 13485 and DHF documentation requirements.

Responsibilities

• Support and maintain Design Controls and Design Assurance activities in a regulated medical device environment.
• Lead CAPA investigations and root cause analysis, and implement corrective actions.
• Perform Risk Management activities including risk assessment, mitigation, and documentation.
• Support Sustaining Engineering activities for existing medical device products.
• Review and assess Engineering Change Orders (ECOs) and DHF documentation.
• Collaborate with Quality, Manufacturing, Supplier Quality, and Engineering teams on cross-functional projects.
• Ensure compliance with applicable FDA, ISO 13485, and medical device quality system requirements.

Skills

Design Controls

Design Assurance

Risk Management

CAPA

RCA

Cross-functional problem solving

Electromechanical

Sustaining Engineering

Change Control

DHF documentation

Regulated environment

Medical device development

Job description

IT Minds LLC seeks two experienced Design Assurance Engineers to back a high-visibility medical device quality initiative in Southern California. You will collaborate with Quality, Manufacturing, Supplier Quality, and Engineering to strengthen design controls, risk management, CAPA execution, sustaining engineering, and change assessment activities.

The role focuses on root cause analysis, CAPA closure, and ensuring DHF documentation and ECO reviews meet FDA and ISO 13485 standards.