Research and Development Engineer I
About The Position
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.
Requirements
- 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).
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
Nice To Haves
- Experience with combination product development and coating processes.
- Knowledge of biocompatibility and sterilization principles.
- Familiarity with regulatory pathways (FDA 510(k), CE Marking).
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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
1,001-5,000 employees
