Engineer II, Design Quality

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 elevate to management as necessary Work on special projects as assigned Requirements 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 Core Competencies 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 Systems CAPA Processes ISO 13485 FDA Compliance Statistical Analysis ATS Optimization Keywords Hard Skills Risk Management Design Controls Document Control Quality Assurance Design Verification Validation Minitab Statistics Product Quality Process Controls Soft Skills Cross-Functional Collaboration Problem Solving Communication Certifications & Qualifications ASQ CQE Industry Keywords Medical Device Standards ISO 14971 MDSAP EU MDR Design History Files #J-18808-Ljbffr