R&D Engineer II

Cordis, LLC; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Cordis, LLC in Irvine, CA, is seeking an R&D Engineer II to advance the development of our next-generation medical device products. You will design, prototype, test, and validate devices, contributing to design transfers and regulatory documentation.

The role requires a Bachelor’s in engineering, 3+ years in medical device development, solid knowledge of design controls and risk management, and proficiency with SolidWorks.

Qualifications

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

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.

Skills

Design controls

Risk management

Education

Bachelor's degree in Mechanical,Biomedical,or Chemical Engineering

Tools

SolidWorks

Job description

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.)