Research and Development Engineer I

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 I 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 Responsibilities

• Collaborate with cross-functional teams including Product Management, Quality, Regulatory, and Manufacturing to define and execute product development strategies.
• Design and develop combination medical devices with attention to usability, safety, manufacturability, and regulatory compliance.
• Conduct research, feasibility studies, and proof-of-concept testing to support new product concepts.
• Prepare detailed engineering specifications, drawings, and documentation for design control.
• Utilize CAD software (SolidWorks preferred) to develop 3D models and 2D drawings of components and assemblies.
• Participate in material and supplier selection to ensure quality and reliability.
• Conduct mechanical, environmental, and functional testing to assess performance and safety.
• Support technology transfer to manufacturing and assist in production ramp-up.
• Stay current with new materials, technologies, and regulations relevant to combination device design.
• Contribute to design dossiers, technical files, and regulatory submissions as required.

Qualifications:

Required Qualifications:

• Bachelor’s degree in Mechanical, Biomedical, or related Engineering discipline.
• 1+ years of experience in R&D, preferably in medical device development.
• Proficiency in CAD modeling (SolidWorks, AutoCAD, or equivalent).
• Understanding of design controls, verification/validation, and risk management (ISO 13485, FDA QSR).

Preferred Qualifications:

• Experience with combination product development and coating processes.
• Knowledge of biocompatibility and sterilization principles.
• Familiarity with regulatory pathways (FDA 510(k), CE Marking).

Key Competencies

• Strong analytical and creative problem-solving abilities.
• Excellent teamwork and communication skills.
• High attention to detail and technical accuracy.
• Ability to manage multiple projects and deadlines.
• Passion for innovation and continuous improvement.

Working Conditions

• Office and laboratory environments.
• May require light lifting (up to 25 lbs.)
• Occasional travel (<10%) to vendors or testing facilities.

Pay / Compensation
The expected pre-tax pay rate for this position is $80,500 - $108,000 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.

Preferred Qualifications:

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.