R&D Engineer II

Overview

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.

Responsibilities

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.

Key Accountabilities

• 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.

Qualifications

Required Qualifications

• 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.

Preferred Qualifications

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

Key Competencies

• Technical proficiency and attention to detail.
• Strong analytical and communication skills.
• Ability to manage multiple priorities in a collaborative environment.
• Problem-solving and continuous improvement mindset.

Working Conditions

• Laboratory and office environment.
• May require standing or bending for extended periods.
• Light lifting (up to 25 lbs.)