Design Assurance Engineer

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

Job Title:

Design Assurance Engineer

Location:

Southern, California

Duration:

12+ Months

Job Description

We are seeking 2 experienced Design Assurance Engineers to support a high-visibility manufacturing and quality initiative for a growing Medical Device organization. The consultant will work closely with Quality, Manufacturing, Supplier Quality, and Engineering teams to strengthen design controls, risk management, CAPA execution, sustaining engineering, and change assessment activities. The role will focus on identifying root causes of product and process issues, implementing Corrective and Preventive Actions (CAPA), improving product reliability, and preventing future quality issues and customer complaints.

Key Responsibilities

• Support and maintain Design Controls and Design Assurance activities in a regulated medical device environment.
• Lead and support CAPA investigations, root cause analysis, corrective actions, and preventive actions.
• Perform Risk Management activities, including risk assessment, risk mitigation, and risk documentation.
• Support Sustaining Engineering activities for existing medical device products.
• Review and assess Engineering Change Orders (ECOs) and product/process changes.
• Maintain and update Design History Files (DHF) and technical documentation.
• Partner with Quality, Manufacturing, Supplier Quality, and Engineering teams on cross-functional projects.
• Conduct Root Cause Analysis (RCA) and implement effective corrective actions.
• Support product and process improvements to enhance product reliability and quality.
• Assist with supplier quality requirements, inspection processes, and manufacturing improvements.
• Support investigations related to product complaints, quality issues, and manufacturing/process deviations.
• Ensure compliance with applicable FDA, ISO 13485, and medical device quality system requirements.

Required Skills

• Strong experience with Design Controls, Design Assurance, and Risk Management.
• Hands-on experience leading CAPA, RCA, and cross-functional problem solving.
• Experience with electromechanical products.
• Experience in Sustaining Engineering, Change Control, and DHF documentation.
• Experience working in a regulated environment.
• Strong understanding of medical device product development and quality processes.