Design Quality Engineer – Medical Devices

ICU Medical; San Clemente (CA); On-site; USD 90,000 - 129,000; Full time

Benefits offered by this job

401(k) match

Benefits options

Paid time off and holidays

Job summary

ICU Medical is seeking a Quality Engineer to support consumable development and ensure compliance with ISO 13485, 21 CFR Part 820, and related standards. You will participate in design reviews, risk assessments, and CAPA data handling while maintaining DHF quality and guiding cross-functional teams.

The role emphasizes strong knowledge of quality systems, risk analysis, and statistical methods (Minitab) to drive product quality improvements and audit readiness across global regulatory

Qualifications

• Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical) or related field is required.
• ASQ CQE certification preferred or ability to obtain within one year.
• Experience with quality systems and design controls preferred.

Responsibilities

• Support CAPA investigations and quality system compliance for ICU Medical consumable development.
• Ensure conformance with FDA and international regulatory requirements.
• Provide guidance on quality standards across product development within the quality system.

Skills

Quality management systems

Design controls

CAPA

Risk analysis

Statistics

Minitab

Education

Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical) or related field

ASQ CQE certification preferred or ability to obtain within one year

Tools

Minitab

Job description

ICU Medical is seeking a Quality Engineer to support consumable development and ensure compliance with ISO 13485, 21 CFR Part 820, and related standards. You will participate in design reviews, risk assessments, and CAPA data handling while maintaining DHF quality and guiding cross-functional teams.

The role emphasizes strong knowledge of quality systems, risk analysis, and statistical methods (Minitab) to drive product quality improvements and audit readiness across global regulatory