Engineer II, Design Quality

ICU Medical

. Provide quality support for ICU Medical Consumables development .

Posted 10/7/2026full-timeSan Clemente • California • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems, risk management, and compliance with medical device regulations. Proficient in supporting CAPA investigations, design projects, and ensuring product quality through validation and design verification.

Highest-signal resume keywords

Quality Management SystemsCAPA InvestigationsISO 13485ISO 14971ASQ CQE Certification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Risk AnalysisDesign VerificationValidationProduct Quality AssuranceProcess Controls

Soft Skills

Cross-Functional CollaborationProblem SolvingCommunication

Certifications & Qualifications

ASQ CQE Certification

Industry Keywords

Medical Device StandardsFDA RegulationsDesign ControlsDocument ControlPost Market Risk Assessments

About the role

Key responsibilities & impact

Provide quality support for ICU Medical Consumables development
Support CAPA investigations, Post Market Risk Assessments, and design projects
Ensure compliance with ICU Medical quality system requirements and applicable regulations and standards
Utilize product and process controls, risk analysis and management tools, validation, design verification, investigations, and CAPA data to assure product quality
Assure conformance with FDA and other international regulatory agency regulations
Ensure quality attributes for design changes are met
Participate in design reviews, test readiness reviews, cross-functional teams, risk assessments, and design transfers
Evaluate, prioritize, and mitigate potential product and process risks
Support internal and external audits and inspections
Interact with cross-functional team members
Provide quality support for on-market product issues, bring issues to closure, and escalate to management as necessary
Work on special projects as assigned

Requirements

What you’ll need

Must be at least 18 years of age
Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical) or related field from an accredited college or university is required
Minimum of two years of experience in R&D and/or Quality is required
Knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.)
Knowledge of medical device standards, including ISO 13485 and ISO 14971
ASQ CQE certification preferred or ability to obtain within one year
Typically requires travel less than 5-10% of the time

Benefits

Comp & perks

Typically requires travel less than 5-10% of the time
Equal Opportunity Employer
Reasonable accommodation for individuals with disabilities during the employment selection process