Design Assurance Engineer

IT Minds LLC; San Diego (CA); On-site; USD 100,000 - 150,000; Full time

Job summary

IT Minds LLC seeks 2 experienced Design Assurance Engineers to support a high-visibility medical device initiative. You will strengthen design controls, risk management, CAPA execution, sustaining engineering, and change assessment reviews across the product portfolio.

The role involves partnering with quality, manufacturing, supplier, and engineering teams to identify root causes, implement corrective actions, improve reliability, and prevent future issues and customer complaints.

Qualifications

• Experience in regulated medical device design controls and risk management.
• Hands-on CAPA leadership and root cause analysis across functions.
• Exposure to DHF documentation and change control processes.

Responsibilities

• Support design controls and risk management activities for the product portfolio.
• Lead CAPA execution and cross-functional problem-solving to prevent issues and improve reliability.
• Review and update technical documentation, and support design/manufacturing changes.
• Help establish robust supplier quality requirements and inspection processes.

Skills

Design controls

Risk management

CAPA leadership

Root cause analysis

Cross-functional teamwork

Sustaining engineering

Change control

DHF documentation

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. This role will focus on strengthening design controls, risk management activities, CAPA execution, sustaining engineering efforts, and change assessment reviews across the product portfolio. The consultant will partner closely with quality, manufacturing, supplier, and engineering teams to identify root causes of product and process issues, implement corrective and preventive actions, improve overall product reliability and help prevent future quality issues and customer complaints. The position also includes reviewing and updating technical documentation, supporting design and manufacturing changes, and helping establish robust supplier quality requirements and inspection processes.

Required Skills:

• Strong experience with design controls, risk management, and design assurance in a regulated environment
• Hands-on CAPA leadership, root cause analysis, and cross-functional problem-solving experience
• Electromechanical product experience with exposure to sustaining engineering, change control, and DHF documentation

Nice to Have:

• Medical device industry experience
• Supplier quality and manufacturing process improvement expertise
• Experience supporting product reliability improvement initiatives or prior Shockwave experience