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
