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 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.

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.