Lead Design Quality Engineer for AI/ML-Enabled MedTech

Jobtailor; California (MO); On-site; USD 90,000 - 130,000; Full time

Job summary

Jobtailor is seeking a Design Quality Engineer to lead cross-functional teams in the development and maintenance of quality systems for AI/ML-enabled medical devices. You will drive design controls, risk management per ISO 14971, and cybersecurity considerations while coordinating with R&D, Regulatory, and Manufacturing teams.

The role emphasizes 8D problem-solving, usability engineering, and ensuring compliance with FDA 21 CFR 820 and ISO 13485 throughout the product lifecycle.

Qualifications

• Bachelor's degree in engineering, life sciences, biomedical engineering, mechanical engineering, electrical engineering, software engineering, quality, or a related technical field.
• Experience in design quality engineering, quality engineering, product development, systems engineering, software quality, AI/ML quality, hardware quality, or a related role in a regulated industry.
• Experience with AI/ML-enabled medical devices, software-enabled medical devices, SaMD, clinical decision support tools, diagnostic algorithms, imaging algorithms, predictive models, or other regulated AI/ML product development.
• Strong working knowledge of medical device design controls.
• Experience owning or maintaining medical device risk management files in accordance with ISO 14971.
• Strong proficiency with 8D problem-solving tools and methods.

Responsibilities

• Support new hardware and software medical device product development.
• Support sustaining product line activities and hardware customer quality activities.
• Serve as Design Quality Project Lead for cross-functional teams.
• Advise teams on design controls, cybersecurity, AI/ML-enabled medical device considerations, risk management, human factors and usability engineering, verification and validation, and mitigations.
• Communicate quality metrics to promote continual improvement and compliance with QMS procedures, laws, regulations, standards, and guidance.
• Develop, establish, and maintain design controls, quality engineering methodologies, systems, and practices.
• Interact with R&D, Program Management, Manufacturing Operations and Engineering, Quality Management Systems, Regulatory, Clinical, Marketing, customer-facing teams, and customers as appropriate.
• Support regulatory, notified body, FDA, internal, customer, supplier, and contract manufacturer audits.
• Support customer issue resolution and cross-functional product quality activities.

Skills

Design Quality Engineering

Risk Management

AI/ML-Enabled Medical Devices

Regulatory Knowledge

Cross-Functional Leadership

Quality Improvement

8D Problem Solving

Technical Communication

Education

Bachelor's degree in engineering or related field

Tools

EQMS

PLM

CAPA

Complaint Investigation Tools

Cybersecurity Standards

Job description

Jobtailor is seeking a Design Quality Engineer to lead cross-functional teams in the development and maintenance of quality systems for AI/ML-enabled medical devices. You will drive design controls, risk management per ISO 14971, and cybersecurity considerations while coordinating with R&D, Regulatory, and Manufacturing teams.

The role emphasizes 8D problem-solving, usability engineering, and ensuring compliance with FDA 21 CFR 820 and ISO 13485 throughout the product lifecycle.