Senior Design Quality Engineer - (Medical Device) - Hybrid in Chicago, IL

Our client is at the forefront of medical device innovation, committed to enhancing patient outcomes with cutting-edge technology and innovative design. They have dedication to quality and are looking for a Senior Design Quality Engineer to join their growing team.

As Senior Design Quality Engineer you will be working 2 days a week onsite in Chicago. In this role, you will ensure the quality and compliance of medical device designs throughout the product development lifecycle. This position requires a deep understanding of design controls, risk management, and regulatory requirements.

Key Responsibilities:

• Lead design quality activities for new product development and sustaining engineering projects.
• Develop and implement design control procedures in line with FDA, ISO 13485, and other regulatory requirements.
• Conduct design reviews, risk assessments, and failure mode effects analysis (FMEA) to ensure product safety and efficacy.
• Collaborate with R&D, manufacturing, regulatory, and marketing teams to meet design quality objectives.
• Review and approve design verification and validation plans, protocols, and reports.
• Support regulatory submissions with necessary design quality documentation and evidence.
• Monitor and analyze design-related quality metrics, driving continuous improvement initiatives.
• Manage all parts of the Quality System - CAPA, Design Controls, Document Controls, Complaints, pFMEA, dFMEA, and uFMEA.
• Stay current with industry trends, standards, and regulations to ensure compliance and innovation.

Qualifications:

• Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical) or relevant field; advanced degree preferred.
• 7-10 years of experience in design quality engineering within the medical device industry.
• Strong knowledge of FDA regulations, ISO 13485, ISO 14971, IEC 60601, and 21 CFR Part 820.
• Proven experience with design controls, risk management, and product development processes.
• Excellent analytical and problem-solving skills, with keen attention to detail.
• Strong communication and interpersonal skills, with the ability to work effectively in a team.
• Certification in quality engineering (e.g., CQE, Six Sigma) is a plus.
• Proficiency in quality management software and tools.

If you would like to learn more about this Senior Design Quality Engineer then apply today or reach out to me:

wjlynch@barringtonjames.com