Title: R&D Quality Engineer IILocation: North Barrington, ILEmployment Type: Full-TimePosition OverviewIf you are passionate about medical device innovation and thrive in fast-paced development environments where quality is built into every stage of the process, this opportunity is for you.
As an R&D Quality Assurance Engineer, you will play a critical role in supporting the development of advanced disposable medical devices from concept through commercialization. Working alongside talented cross-functional teams, you'll help ensure products are designed, validated, and manufactured to meet the highest standards of quality, safety, compliance, and performance.
This role offers the opportunity to work on cutting-edge catheter and delivery system technologies supporting specialties such as cardiology, neurology, and urology - directly contributing to products that improve patient outcomes worldwide.
What You'll DoAs an R&D Quality Assurance Engineer, you will support the development and commercialization of advanced disposable medical devices by ensuring products are designed, validated, and manufactured in compliance with internal quality systems and regulatory requirements. You will partner closely with R&D, Manufacturing, Quality, and Regulatory teams to drive quality throughout the product lifecycle - from concept through production transfer.
Key Responsibilities- Represent Quality on cross-functional R&D and product development teams.
- Support design controls, risk management activities, and Design History File (DHF) development in compliance with ISO 13485, ISO 14971, and FDA 21 CFR Part 820 requirements.
- Review engineering drawings, specifications, procedures, and validation documentation to ensure quality and manufacturability.
- Execute and support testing and validation activities including design verification/validation, process validation, and test method validation.
- Support nonconformance investigations, CAPAs, root cause analysis, and continuous improvement initiatives.
- Develop and maintain inspection procedures, quality documentation, and metrology methods.
- Participate in supplier quality activities, audits, and customer quality communications as needed.
- Collaborate with cross-functional teams to ensure projects meet quality, delivery, and customer expectations.
What You'll BringEducation & Experience- BS or MS in Engineering or related technical discipline
(or equivalent combination of education and relevant experience) - 2-5 years of experience in Quality Engineering or R&D Engineering within the medical device industry.
- Experience supporting regulated product development and manufacturing environments preferred.
- Familiarity with ISO 13485, ISO 14971, and FDA 21 CFR Part 820 requirements.
- Experience with Design Controls, Design History Files (DHFs), validation activities, and medical device testing preferred.
- Green Belt Certification is a plus.
Qualifications & Technical Skills- Strong understanding of medical device quality systems and risk management principles.
- Experience supporting design verification/validation, process validation, and root cause investigations.
- Strong technical writing skills for protocols, reports, and data analysis.
- Working knowledge of statistics, SPC, and data analysis methods.
- Proficiency with Microsoft Office and related business systems.
- Excellent analytical, organizational, and problem-solving skills.
- Strong communication and collaboration skills with the ability to work effectively across cross-functional teams.
- Ability to manage multiple priorities in a fast-paced development environment.
- Detail-oriented with a strong commitment to quality, compliance, and continuous improvement.
