Senior Engineer, Design Quality

ICU Medical

Senior Design Quality Engineer ensuring medical-device quality and regulatory compliance at ICU Medical. Coordinating design controls, risk management, CAPA, audits, and product-quality improvements in San Clemente’s hybrid workplace.

Posted 8/12/2026full-timeSan Clemente • California • 🇺🇸 United StatesSenior💰 $140,774 - $161,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems and compliance with FDA and ISO regulations, particularly in the Medical Device Industry. Proficient in risk management, design controls, and CAPA processes, with a strong ability to analyze data and support audits.

Highest-signal resume keywords

Medical Device Industry ExpertiseISO 13485 ComplianceFDA QSR RegulationsRisk Management DocumentationDesign Control Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management SystemsStatistical Analysis TechniquesDesign Verification ProtocolsRisk AssessmentsCAPA ActivitiesDesign History Files ManagementDevice Master Records Management510K SubmissionsTechnical File SubmissionsInvestigations

Industry Keywords

FDA ComplianceISO 14971REACH RegulationsRoHS RegulationsProduct Quality AssuranceCross-Functional Team CoordinationInternal AuditsExternal InspectionsProduct Change CoordinationManufacturing Quality Data Analysis

About the role

Key responsibilities & impact

Utilize quality tools and processes, including product and process controls, risk analysis and management, validation, design verification, investigations, and CAPA data, to assure product quality
Ensure conformance with FDA and international regulatory agency requirements for medical devices
Provide compliance guidance on quality standards related to product development within the quality system
Coordinate product changes with cross-functional teams
Participate in design reviews, test readiness reviews, risk assessments, design transfers, and cross-functional teams
Provide corporate quality support for resolving on-market product issues and escalate to senior management when necessary
Evaluate, prioritize, and mitigate product and process risks
Analyze product reviews, global complaints, manufacturing quality data, and other data sources
Monitor product data for statistically significant trends and risks
Ensure compliance, alignment, and consistency with ICU Medical’s quality system
Prepare for and support internal and external audits and inspections
Work on special projects as assigned

Requirements

What you’ll need

Bachelor’s degree (or foreign equivalent) in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Software Engineering, or closely related field
Seven (7) years of experience in the job offered or a closely related occupation
Expertise in the Medical Device Industry
Experience with ISO and FDA QSR regulations, including ISO 13485 and ISO 14971
Knowledge of Quality Management Systems and experience linking risk management to Design Controls, CAPA, Complaints, and Document Control
Experience managing Design Control elements, Design History Files, and Device Master Records
Experience supporting 510K and Technical File submissions
Experience creating Design V&V protocols and reports
Experience initiating and managing Risk Management documents, including HA, DFMEA, and PFMEA
Familiarity with international REACH and RoHS regulations
Experience with investigations, risk assessments, and associated CAPA activities
Knowledge of statistical analysis techniques
Experience with quality compliance, audits, and investigations
Must possess expertise/knowledge sufficient to perform the duties of the job

Benefits

Comp & perks

Hybrid work from home is permissible
5-10% domestic and international travel required per year