Engineer II, Design Quality

ICU Medical

Design Quality Engineer supporting ICU Medical’s medical-device consumable development. Managing CAPA, risk, design controls, audits, and regulatory compliance.

Posted 8/13/2026full-timeSouthington • Connecticut • 🇺🇸 United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems, regulatory compliance, and risk management for medical device development. Proficient in CAPA processes, design controls, and statistical analysis to ensure product quality and compliance with industry standards.

Highest-signal resume keywords

Quality Management SystemsCAPA ProcessesISO 13485FDA ComplianceStatistical Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Risk ManagementDesign ControlsDocument ControlQuality AssuranceDesign VerificationValidationMinitabStatisticsProduct QualityProcess Controls

Soft Skills

Cross-Functional CollaborationProblem SolvingCommunication

Certifications & Qualifications

ASQ CQE

Industry Keywords

Medical Device StandardsISO 14971MDSAPEU MDRDesign History Files

About the role

Key responsibilities & impact

Provide quality support for ICU Medical Consumable development
Support CAPA investigations and design projects
Ensure compliance with ICU Medical quality system requirements and applicable regulations and standards
Utilize product and process controls, risk analysis/management tools, validation, design verification, investigations, and CAPA data to assure product quality
Assure conformance with FDA and other international regulatory agency regulations
Support development, application, and maintenance of quality standards
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
Maintain Design History Files up to date
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 linking risk management to Quality System elements
Knowledge of medical device standards, including ISO 13485, MDSAP, EU MDR, and ISO 14971
Knowledge of statistics, including tolerance limits and Cpk
Minitab knowledge is preferred
ASQ CQE certification is preferred
Knowledge of design controls, CAPA, complaints, and document control
Ability to support FDA and international regulatory compliance
Ability to 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 and equal access and opportunities for candidates with disabilities