Design Quality Engineer

Intellectt Inc; Carlsbad (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

Intellectt Inc. is seeking a candidate for critical design quality initiatives in Carlsbad, California. This role entails leading design change assessments and supporting risk management documentation for an electromechanical product line.

The ideal candidate will have strong analytical skills, experience managing CAPAs, and expertise in design validation activities, contributing to ongoing product improvements.

Qualifications

• Strong analytical skills necessary for problem solving.
• Experience in a regulated (medical device) environment required.

Responsibilities

• Manage change orders and investigate product issues.
• Support corrective and preventive actions (CAPAs).
• Contribute to design validation activities tied to product improvements.

Skills

CAPA ownership

Root cause analysis

Design change assessments

Risk management documentation

Electromechanical product experience

Job description

Our client is looking for someone to help support critical design quality initiatives for an electromechanical product line. This role focuses on leading design change assessments, supporting risk management documentation, and contributing to design validation activities tied to ongoing product improvements. You’ll work closely with cross-functional teams to manage change orders, investigate product issues, and support corrective and preventive actions (CAPAs). The position requires strong analytical skills, hands on problem solving, and experience navigating quality systems in a regulated environment.

Required Skills

• Experience with CAPA ownership, investigations, and root cause analysis.
• Background in design change assessments and risk management documentation.
• Electromechanical product experience within a regulated (medical device) environment.

Nice to Have

• Experience supporting design validation and authoring technical reports.
• Exposure to field failure investigations and associated quality processes.