Cordis · 14 hours ago
Research and Development Engineer I
Irvine, CA
Full-time
Onsite
Entry Level
$80K/yr - $108K/yr
1+ years expCordis, in partnership with Selution, specializes in the development of innovative drug device combination products for treating coronary and peripheral artery disease. They are seeking an R&D Engineer I to contribute to the design, prototyping, testing, and validation of medical devices that aim to transform patient care.
Health CareHealth DiagnosticsMedical
No H1B
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
Qualification
Required
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
Experience with combination product development and coating processes
Knowledge of biocompatibility and sterilization principles
Familiarity with regulatory pathways (FDA 510(k), CE Marking)
Company
Cordis
Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2021-03-12Acquired
Leadership Team
Scott Drake
Chief Executive Officer
Recent News
2025-11-11
TeamBest Global Companies
2025-11-07
News-Medical.Net
2025-11-01
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