R&D Engineer II

Cordis; Irvine (CA); On-site; USD 79,000 - 106,000; Full time

Job summary

Cordis in Irvine, California is seeking an ambitious R&D Engineer II to contribute to the development and optimization of their combination medical devices for cardiovascular applications.

You will work with a multidisciplinary team on design, prototyping, testing, and validation, ensuring robust design transfer and regulatory readiness in a collaborative laboratory and office setting.

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.

Responsibilities

• Execute product and process development activities including design, testing, and analysis.
• Support design verification and validation protocols through testing and documentation.
• 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.

Skills

Product development

Design controls

Risk management

CAD software

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.)

Pay / Compensation

The expected pre-tax pay rate for this position is $78,650 - $105,600 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work‑authorized visa.

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammates’ points of view are key to our success, and we believe inclusion is everyone’s responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.