Senior Design Quality Engineer – Medical Devices

Jobtailor; Irvine (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Jobtailor seeks a Quality Engineer Leader in Irvine, CA to drive reliability studies, DOE, and design characterization across development to commercialization. You will guide risk management, implement robust test methods, and mentor cross-functional teams to improve device performance and manufacturability.

Applicants should bring advanced statistical analysis skills (Minitab, capability, stability), knowledge of ISO 13485, EU MDR, FDA QSR, and a track record in vascular or neurovascular

Qualifications

• Bachelor's degree in Engineering or Science; 4+ years engineering/quality experience or advanced degree with 2+ years experience.
• Experience supporting product development, design quality or quality engineering activities.
• Experience applying statistical analysis and data-driven problem-solving techniques.
• Experience in regulated environments with design control, risk management, verification or validation.

Responsibilities

• Lead reliability studies, design characterization activities, and DOE.
• Apply risk management to identify and mitigate product/process risks from development through commercialization.
• Develop/test methods, statistical approaches and process controls to meet reliability and quality objectives.
• Analyze product performance data and process metrics to identify improvement opportunities and support decisions.
• Provide quality engineering leadership for verification, validation, and design transfer.

Skills

Statistical Analysis

Design of Experiments (DOE)

Risk Management

Quality Engineering

Product Development

Design Quality Engineering

Process Controls

Reliability Studies

Data-Driven Problem Solving

Requirements Flow-Down

Education

Bachelor's degree in Engineering or Science

Advanced degree (Engineering or Science)

Tools

Minitab

Graphical Analysis

Capability Analysis

Stability Analysis

Job description

Jobtailor seeks a Quality Engineer Leader in Irvine, CA to drive reliability studies, DOE, and design characterization across development to commercialization. You will guide risk management, implement robust test methods, and mentor cross-functional teams to improve device performance and manufacturability.

Applicants should bring advanced statistical analysis skills (Minitab, capability, stability), knowledge of ISO 13485, EU MDR, FDA QSR, and a track record in vascular or neurovascular