Senior Engineer, Design Quality

Jobtailor; San Clemente (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

ICU Medical in the United States is seeking an experienced quality professional to assure product quality and regulatory compliance across the lifecycle. You will drive risk analyses, CAPA, design verification, and investigations while coordinating with cross-functional teams to support audits and inspections.

The role requires a strong background in medical device quality systems, ISO 13485, ISO 14971, and FDA QSR, with leadership in Design Controls and DHF/MDR management.

Qualifications

• Bachelor's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Software Engineering, or closely related field

Responsibilities

• 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 escape 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

Skills

Quality Management Systems

Statistical Analysis Techniques

Design Verification Protocols

Risk Assessments

CAPA Activities

Design History Files Management

Device Master Records Management

510K Submissions

Technical File Submissions

Investigations

Education

Bachelor's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Software Engineering, or closely related field

Job description

• 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 escape 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

• 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

Core Competencies

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 Expertise
• ISO 13485 Compliance
• FDA QSR Regulations
• Risk Management Documentation
• Design Control Management

ATS Optimization Keywords

Hard Skills

• Quality Management Systems
• Statistical Analysis Techniques
• Design Verification Protocols
• Risk Assessments
• CAPA Activities
• Design History Files Management
• Device Master Records Management
• 510K Submissions
• Technical File Submissions
• Investigations

Industry Keywords

• FDA Compliance
• ISO 14971
• REACH Regulations
• RoHS Regulations
• Product Quality Assurance
• Cross-Functional Team Coordination
• Internal Audits
• External Inspections
• Product Change Coordination
• Manufacturing Quality Data Analysis