R&D Engineer II

Cordis • Irvine, CA

8d • Onsite

About The Position

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. We are seeking a talented and motivated R&D Engineer II to join our dynamic team of innovators in Irvine, California. As an R&D Engineer, you will play a pivotal role in the development and enhancement of our combination medical devices. Working closely with a multidisciplinary team, you will contribute to the design, prototyping, testing, and validation of innovative medical devices that have the potential to transform patient care.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, or Chemical Engineering.
• 3+ years of experience in medical device product development or combination of education and experience.
• Strong knowledge of design controls and risk management principles.
• Proficiency with SolidWorks or equivalent CAD software.

Nice To Haves

• Experience with combination product development.
• Familiarity with balloon catheter manufacturing or coating processes.

Responsibilities

• Execute product and process development activities including design, testing, and analysis.
• Support development and execution of design verification and validation protocols.
• Prepare and maintain design documentation, including drawings, specifications, and reports.
• Perform failure analysis and recommend design or process improvements.
• Collaborate with Manufacturing, Quality, and Analytical teams to ensure robust design transfer.
• Support regulatory submissions by providing engineering documentation and test data.
• Participate in risk assessments and implement design mitigation strategies.
• Maintain compliance with ISO 13485, FDA 21 CFR Part 820, and company procedures.
• Contribute to continuous improvement of design and development processes.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level